CSL

Job Description SummaryResponsible for preparing the donor, donor area and equipment for the pheresis process. Job Description1 Prepares the autopheresis machine for the pheresis process. 2 Monitors the donor and the pheresis process, responds to specific alarms or signals that may occur during the process. 3 Disconnects the donor when the process is complete. 4 Maintains alertness and awareness to any reaction donor may have during or after the pheresis process and notifies appropriate staff. 5 Uses Personal Digital Assistant (PDA) to record incidents that occur during the pheresis process, such as machine alerts and alarms, volume variances and donor adverse events. 6 Uses PDA to link equipment and soft goods used in the pheresis process to the appropriate donor. 7 Alerts Group Leader or Supervisor of donor flow issues. 8 Ensures the accurate recording of donor data in the electronic donor information management system as outlined in the Standard Operating Procedures (SOPs). 9 Understands the policies and procedures associated with hyper immune programs at the center if applicable. 10 Maintains clean efficient work environment, and ensures sufficient operating supplies and forms are available as needed. Follows all Health Safety & Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Promotes safety in all actions. 11 Maintains confidentiality of all personnel, donor and center information. 12 May be cross-trained in other areas to meet the needs of the business. 13 Bilingual skills may be required, at the discretion of the organization, to meet the needs of the business. 14 Perform job-related duties as assigned. Education • High school diploma or equivalent required Experience • Minimum of three (3) months’ work experience, preferably in medical or health provider environment or equivalent combination of education and experience • Must be able to perform basic math calculations Working Conditions (physical & mental requirements) • Ability to understand, remember and apply oral and/or written instructions • Ability to understand and follow basic instructions and guidelines • Must be able to see and speak with customers and observe equipment operation. • Occasionally perform tasks while standing and walking up to 100% of time • Reach, bend, kneel and have high level of manual dexterity • Occasionally be required to lift and carry up to 25 pounds • Fast paced environment with frequent interruptions • Frequently exposed to hazardous chemicals, extreme temperatures and to blood borne pathogens • Required to wear Personal Protective Equipment while performing specific tasks or in certain areas • Required to work overtime and extended hours to support center operational needs All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications. Our BenefitsFor more information on CSL Plasma benefits visit https://cslbenefits.com/cslp. About CSL PlasmaCSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Plasma!

The Opportunity Responsible for the efficient and effective collection of plasma from donors by performing venipuncture, monitoring the pheresis process and following Standard Operating Procedures (SOPs). You will report to the Assistant Center Manager The Role In compliance with SOPs perform all aspects of the pheresis procedure and plasma collection, including donor set-up, donor monitoring and donor disconnect.In compliance with SOPs and Food & Drug Administration (FDA) guidelines, performs venipuncture on donors to begin pheresis process.Evaluates vein performance of the donor to identify possible problems; makes necessary corrections in order to expedite donation time and ensure product quality and donor safety. Ensures donation process is efficient and makes adjustments when necessary to make the process a positive experience for the donor.May educate new donors on the use of therapeutic products made from donated plasma. Explains the screening process, the health screening tests performed, the appointment system, donation fees, center policies, proper nutrition and any other information pertinent to the donor. Ensures that all donor questions are answered timely, accurately and professionally.Maintains alertness to any reaction by donors and assists with reactions or notifies appropriate staff.Uses Personal Digital Assistant (PDA) to record incidents that occur during the pheresis process, such as machine alerts and alarms, volume variances and donor adverse events.Required to perform calibrations and verify that maintenance has been performed as outlined in the SOPs. Required to respond to and resolve complex equipment alarms or donor issues.Troubleshoots equipment failures. Creates incident documentation, removes and/or replaces equipment from service.Monitors donor flow on the donor floor to assure continuous turnover. Alerts Group Leader or Supervisor of donor flow issues.Collects arm samples or whole blood samples from donors for testing.Ensures the accurate recording of donor data in the electronic donor information management system as outlined in the Standard Operating Procedures (SOPs).Understands the policies and procedures associated with hyper immune programs at the center if applicable.Maintains clean efficient work environment, and ensures sufficient operating supplies and forms are available as needed. Follows all Health Safety & Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Promotes safety in all actions. May conduct routine audits of these internal procedures and documentation.Maintains confidentiality of all personnel, donor and center information.May be cross-trained in other areas to meet the needs of the business.Bilingual skills may be required, at the discretion of the organization, to meet the needs of the business.Perform other job-related duties as assigned. Your skills and experience Education High school diploma or equivalent required Experience Minimum eighteen (12) months experience in a medical or health care environment preferred or equivalent combination of education and experience Working Conditions (physical & mental requirements) Ability to complete routine forms or conduct routine oral communicationsUnderstands, remembers and communicates routine, factual informationMust be able to see and speak with customers and observe equipment operationOccasionally perform tasks while standing and walking up to 100% of timeReach, bend, kneel and have high level of manual dexterityOccasionally be required to lift and carry up to 25 poundsFast paced environment with frequent interruptionsFrequently exposed to hazardous chemicals, extreme temperatures and to blood borne pathogensRequired to wear Personal Protective Equipment while performing specific tasks or in certain areasRequired to work overtime and extended hours to support center operational needs Our BenefitsCSL offers the following benefits for this part-time position: Paid sick leave; and the option to participate in CSL’s 401(k) Savings Program. For more information on CSL Plasma benefits visit https://cslbenefits.com/cslp. About CSL PlasmaCSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Plasma!

The Opportunity Responsible for the efficient and effective collection of plasma from donors by performing venipuncture, monitoring the pheresis process and following Standard Operating Procedures (SOPs). You will report to the Assistant Center Manager The Role In compliance with SOPs perform all aspects of the pheresis procedure and plasma collection, including donor set-up, donor monitoring and donor disconnect.In compliance with SOPs and Food & Drug Administration (FDA) guidelines, performs venipuncture on donors to begin pheresis process.Evaluates vein performance of the donor to identify possible problems; makes necessary corrections in order to expedite donation time and ensure product quality and donor safety. Ensures donation process is efficient and makes adjustments when necessary to make the process a positive experience for the donor.May educate new donors on the use of therapeutic products made from donated plasma. Explains the screening process, the health screening tests performed, the appointment system, donation fees, center policies, proper nutrition and any other information pertinent to the donor. Ensures that all donor questions are answered timely, accurately and professionally.Maintains alertness to any reaction by donors and assists with reactions or notifies appropriate staff.Uses Personal Digital Assistant (PDA) to record incidents that occur during the pheresis process, such as machine alerts and alarms, volume variances and donor adverse events.Required to perform calibrations and verify that maintenance has been performed as outlined in the SOPs. Required to respond to and resolve complex equipment alarms or donor issues.Troubleshoots equipment failures. Creates incident documentation, removes and/or replaces equipment from service.Monitors donor flow on the donor floor to assure continuous turnover. Alerts Group Leader or Supervisor of donor flow issues.Collects arm samples or whole blood samples from donors for testing.Ensures the accurate recording of donor data in the electronic donor information management system as outlined in the Standard Operating Procedures (SOPs).Understands the policies and procedures associated with hyper immune programs at the center if applicable.Maintains clean efficient work environment, and ensures sufficient operating supplies and forms are available as needed. Follows all Health Safety & Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Promotes safety in all actions. May conduct routine audits of these internal procedures and documentation.Maintains confidentiality of all personnel, donor and center information.May be cross-trained in other areas to meet the needs of the business.Bilingual skills may be required, at the discretion of the organization, to meet the needs of the business.Perform other job-related duties as assigned. Your skills and experience Education High school diploma or equivalent required Experience Minimum eighteen (12) months experience in a medical or health care environment preferred or equivalent combination of education and experience Working Conditions (physical & mental requirements) Ability to complete routine forms or conduct routine oral communicationsUnderstands, remembers and communicates routine, factual informationMust be able to see and speak with customers and observe equipment operationOccasionally perform tasks while standing and walking up to 100% of timeReach, bend, kneel and have high level of manual dexterityOccasionally be required to lift and carry up to 25 poundsFast paced environment with frequent interruptionsFrequently exposed to hazardous chemicals, extreme temperatures and to blood borne pathogensRequired to wear Personal Protective Equipment while performing specific tasks or in certain areasRequired to work overtime and extended hours to support center operational needs Our BenefitsCSL offers the following benefits for this full-time position: Options for health care benefits, including choices of plans for medical, dental, and vision, prescription drug coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSL’s 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company. For more information on CSL Plasma benefits visit https://cslbenefits.com/cslp. About CSL PlasmaCSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Plasma!

Job Description SummaryResponsible for greeting donors at the plasma collection center and conducting a series of registration procedures to verify donor suitability for the plasma pheresis process. Job Description1 In compliance with Standard Operating Procedures (SOPs), assists qualified donors in completing the screening process. The screening procedures includes but are not limited to: assessing the self-administered health history, answering basic medical questions associated with the donation process, referring donors to medical staff when appropriate and performing health screening procedures such as blood pressure, pulse, weight, temperature. Performs finger stick to obtain sample to obtain donor’s hematocrit and total protein levels. 2 Upon completion of the appropriate training, may educate new donors on the use of therapeutic products made from donated plasma. This includes explaining the screening process, the health screening tests performed, the appointment system, donation fees, center policies, proper nutrition and any other information pertinent to the donor. Ensures that all donor questions are answered timely, accurately and professionally. 3 May be involved in registering applicant and transfer donors based upon completion of appropriate training and operational needs of the center. 4 May answer the telephone and answer callers question or transfer call to appropriate staff member. 5 Maintains alertness and awareness to any reaction by a donor may have during or after the pheresis process and notifies appropriate staff. 6 Alerts Group Leader or Supervisor of donor flow issues. 7 Ensures the accurate recording of donor data in the electronic donor information management system as outlined in the SOPs. 8 Understands the policies and procedures associated with hyper immune programs at the center if applicable. 9 Maintains clean efficient work environment and ensures sufficient operating supplies and forms are available as needed. Follows all Health Safety & Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Promotes safety in all actions. 10 Maintains confidentiality of all personnel, donor and center information. 11 May be cross-trained in other areas to meet the needs of the business. 12 Bilingual skills may be required, at the discretion of the organization, to meet the needs of the business. 13 Perform other job-related duties as assigned. Education • High school diploma or equivalent required Experience • Minimum of three (3) months experience in a clerical or customer service related position, preferably in medical or health provider environment or equivalent combination of education and experience • Must be able to perform basic math calculations Working Conditions • Ability to understand, remember and apply oral and/or written instructions • Ability to understand and follow basic instructions and guidelines • Must be able to see and speak with customers and observe equipment operation. • Occasionally perform tasks while standing and walking up to 100% of time • Reach, bend, kneel and have high level of manual dexterity • Occasionally be required to lift and carry up to 25 pounds • Fast paced environment with frequent interruptions • Frequently exposed to hazardous chemicals, extreme temperatures and to blood borne pathogens • Required to wear Personal Protective Equipment while performing specific tasks or in certain areas • Required to work overtime and extended hours to support center operational needs All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications. Our BenefitsFor more information on CSL Plasma benefits visit https://cslbenefits.com/cslp. About CSL PlasmaCSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Plasma!

Job DescriptionJob Description SummaryResponsible for the accurate and timely sampling, testing, shipping and storage of plasma collected from donors. Job Description1 In compliance with Standard Operating Procedures (SOPs), responsible for collecting plasma samples and moving plasma units to freezer to ensure product quality. 2 Ensures plasma units are properly stored according to SOPs, which could include unsuitable plasma units and samples. 3 Ensures accuracy of unit labeling by verifying the pre-printed label matches the dynamic label. 4 Utilizes sterile technique to draw samples and uses heat sealer to assure the sterility and quality of plasma unit samples per SOPs. 5 May ensure samples and units are packed and shipped in accordance with SOPs and center procedures. Prepares shipping and unit disposal documentation. 6 Monitors freezer and refrigerator temperatures and immediately informs appropriate personnel if equipment is not functioning properly. Records variances. 7 Conducts daily calibration of equipment according to SOPs. 8 Ensures the accurate recording of donor data in the electronic donor information management system as outlined in the SOPs. 9 Understands the policies and procedures associated with hyper immune programs at the center if applicable. 10 Maintains clean efficient work environment, and ensures sufficient operating supplies and forms are available as needed. Follows all Health Safety & Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Promotes safety in all actions. 11 Maintains confidentiality of all personnel, donor and center information. 12 May be cross-trained in other areas to meet the needs of the business. 13 Bilingual skills may be required, at the discretion of the organization, to meet the needs of the business. 14 Perform other job-related duties as assigned. Education • High school diploma or equivalent required Experience • Minimum of three (3) months experience in laboratory or warehouse environment preferred or equivalent combination of education and experience • Must be able to perform basic math calculations Working Conditions (physical & mental requirements) • Ability to understand, remember and apply oral and/or written instructions • Ability to understand and follow basic instructions and guidelines • Must be able to see and speak with customers and observe equipment operation. • Occasionally perform tasks while standing and walking up to 100% of time • Reach, bend, kneel and have high level of manual dexterity • Occasionally be required to lift and carry up to 25 pounds • Fast paced environment with frequent interruptions • Frequently exposed to hazardous chemicals, extreme temperatures and to blood borne pathogens • Required to wear Personal Protective Equipment while performing specific tasks or in certain areas • Required to work overtime and extended hours to support center operational needs All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications. Please note, we may not have an immediate need at the present time; however we are always interested in speaking to well qualified candidates for future openings. If you are interested in exploring a career with CSL, please apply. Someone will follow up depending on the current needs, but please be aware correspondence may not be immediate. CSL offers the following benefits for this part-time position: Paid sick leave; and the option to participate in CSL’s 401(k) Savings Program. Our BenefitsFor more information on CSL Plasma benefits visit https://cslbenefits.com/cslp. About CSL PlasmaCSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Plasma!

Job Description SummaryResponsible for greeting donors at the plasma collection center and conducting a series of registration procedures to verify donor suitability for the plasma pheresis process. Job Description1 In compliance with Standard Operating Procedures (SOPs), assists qualified donors in completing the screening process. The screening procedures includes but are not limited to: assessing the self-administered health history, answering basic medical questions associated with the donation process, referring donors to medical staff when appropriate and performing health screening procedures such as blood pressure, pulse, weight, temperature. Performs finger stick to obtain sample to obtain donor’s hematocrit and total protein levels. 2 Upon completion of the appropriate training, may educate new donors on the use of therapeutic products made from donated plasma. This includes explaining the screening process, the health screening tests performed, the appointment system, donation fees, center policies, proper nutrition and any other information pertinent to the donor. Ensures that all donor questions are answered timely, accurately and professionally. 3 May be involved in registering applicant and transfer donors based upon completion of appropriate training and operational needs of the center. 4 May answer the telephone and answer callers question or transfer call to appropriate staff member. 5 Maintains alertness and awareness to any reaction by a donor may have during or after the pheresis process and notifies appropriate staff. 6 Alerts Group Leader or Supervisor of donor flow issues. 7 Ensures the accurate recording of donor data in the electronic donor information management system as outlined in the SOPs. 8 Understands the policies and procedures associated with hyper immune programs at the center if applicable. 9 Maintains clean efficient work environment and ensures sufficient operating supplies and forms are available as needed. Follows all Health Safety & Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Promotes safety in all actions. 10 Maintains confidentiality of all personnel, donor and center information. 11 May be cross-trained in other areas to meet the needs of the business. 12 Bilingual skills may be required, at the discretion of the organization, to meet the needs of the business. 13 Perform other job-related duties as assigned. Education • High school diploma or equivalent required Experience • Minimum of three (3) months experience in a clerical or customer service related position, preferably in medical or health provider environment or equivalent combination of education and experience • Must be able to perform basic math calculations Working Conditions • Ability to understand, remember and apply oral and/or written instructions • Ability to understand and follow basic instructions and guidelines • Must be able to see and speak with customers and observe equipment operation. • Occasionally perform tasks while standing and walking up to 100% of time • Reach, bend, kneel and have high level of manual dexterity • Occasionally be required to lift and carry up to 25 pounds • Fast paced environment with frequent interruptions • Frequently exposed to hazardous chemicals, extreme temperatures and to blood borne pathogens • Required to wear Personal Protective Equipment while performing specific tasks or in certain areas • Required to work overtime and extended hours to support center operational needs All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications. Please note, we may not have an immediate need at the present time; however we are always interested in speaking to well qualified candidates for future openings. If you are interested in exploring a career with CSL, please apply. Someone will follow up depending on the current needs, but please be aware correspondence may not be immediate. CSL offers the following benefits for this part-time position: Paid sick leave; and the option to participate in CSL’s 401(k) Savings Program. Our BenefitsFor more information on CSL Plasma benefits visit https://cslbenefits.com/cslp. About CSL PlasmaCSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Plasma!

Job DescriptionJob Description SummaryResponsible for preparing the donor, donor area and equipment for the pheresis process. Job DescriptionMain Responsibilities 1. Prepares the autopheresis machine for the pheresis process. 2. Monitors the donor and the pheresis process, responds to specific alarms or signals that may occur during the process. 3. Disconnects the donor when the process is complete. 4. Maintains alertness and awareness to any reaction donor may have during or after the pheresis process and notifies appropriate staff. 5. Uses Personal Digital Assistant (PDA) to record incidents that occur during the pheresis process, such as machine alerts and alarms, volume variances and donor adverse events. 6. Uses PDA to link equipment and soft goods used in the pheresis process to the appropriate donor. 7. Alerts Group Leader or Supervisor of donor flow issues. 8. Ensures the accurate recording of donor data in the electronic donor information management system as outlined in the Standard Operating Procedures (SOPs). 9. Understands the policies and procedures associated with hyper immune programs at the center if applicable. 10. Maintains clean efficient work environment, and ensures sufficient operating supplies and forms are available as needed. Follows all Health Safety & Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Promotes safety in all actions. 11. Maintains confidentiality of all personnel, donor and center information. 12. May be cross-trained in other areas to meet the needs of the business. 13. Bilingual skills may be required, at the discretion of the organization, to meet the needs of the business. 14. Perform job-related duties as assigned. Education  High school diploma or equivalent required Experience  Minimum of three (3) months’ work experience, preferably in medical or health provider environment or equivalent combination of education and experience  Must be able to perform basic math calculations Working Conditions (physical & mental requirements)  Ability to understand, remember and apply oral and/or written instructions  Ability to understand and follow basic instructions and guidelines  Must be able to see and speak with customers and observe equipment operation.  Occasionally perform tasks while standing and walking up to 100% of time  Reach, bend, kneel and have high level of manual dexterity  Occasionally be required to lift and carry up to 25 pounds  Fast paced environment with frequent interruptions  Frequently exposed to hazardous chemicals, extreme temperatures and to blood borne pathogens  Required to wear Personal Protective Equipment while performing specific tasks or in certain areas  Required to work overtime and extended hours to support center operational needs Note: All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications. Please note, we may not have an immediate need at the present time; however we are always interested in speaking to well qualified candidates for future openings. If you are interested in exploring a career with CSL, please apply. Someone will follow up depending on the current needs, but please be aware correspondence may not be immediate. CSL offers the following benefits for this part-time position: Paid sick leave; and the option to participate in CSL’s 401(k) Savings Program. Our BenefitsFor more information on CSL Plasma benefits visit https://cslbenefits.com/cslp. About CSL PlasmaCSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Plasma!

Job Description Summary This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations. • Reporting compliance status data to operational quality management • Collaborate with center management in the development and implementation of continuous improvement plans • Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during internal and external audits, responds to questions, and may stop operations, including shipments to address quality concerns • Responsible for coordinating and managing training activities, policies and processes at the center level ​Job Description 1 Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications. 2 Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 3 Perform center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 4 Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements. 5 Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards. 6 Initiates schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements. Ensure the most current version of training materials at the center is being used 7 Collaborates with center management when viewing the Quality Management System to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues. 8 Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management. 9 Identifying and communicate non-conformities to CSL’s SOP’s. In the absence of the AQM, may conduct monthly quality team meeting to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation. 10 Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center. 11 Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers. 12 Responsible to initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective. 13 Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable. 14 Follow all Standard Operating Procedures (SOPs), company policies and procedures. 15 Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA. 16 Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable. 17 Assist Plasma center staff in completing other special projects or assignments, as requested. 18 Perform other job-related duties, as assigned. Education • High school diploma or equivalent required. Associate or Bachelor’s degree in business administration or biological sciences preferred. Experience • Minimum 1-year leadership experience or equivalent of one-year experience in a regulated environment. • Strong customer service skills • Strong critical reasoning, decision-making and problem solving skills to analyze situations • Organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives • Understand Quality Systems and/or regulated training requirements Working Conditions (physical & mental requirements) • Occasionally required to work with the public when they are dissatisfied • 80% of the time standing and walking and 20% of the time sitting • Reach, bend, kneel and have high level of manual dexterity • See and speak with customers and observe equipment operation • Occasionally be required to lift and carry 25 lbs. • Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications. #CB #CB Please note, we may not have an immediate need at the present time; however we are always interested in speaking to well qualified candidates for future openings. If you are interested in exploring a career with CSL, please apply. Someone will follow up depending on the current needs, but please be aware correspondence may not be immediate. CSL offers the following benefits for this full-time position, most are effective the first day of hire: Options for health care benefits, including choices of plans for medical and prescription drug, dental, and vision coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSL’s 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company. Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSL PlasmaCSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Plasma!

Für die Abteilung Qualitätssicherung CSL Plasma in Göttingen suchen wir ab sofort einenMitarbeiter (m/w) im Qualitätsmanagement zur Ausbildung zum GxP-Auditor mit sehr guten Sprachkenntnissen in Deutsch, Italienisch, Französisch oder Spanisch (verhandlungssicher) (Vollzeit / befristet)Ihre Tätigkeiten: - Unterstützung der Teamleitung in der Betreuung und Qualifizierung von Plasmalieferanten / Dienstleistern im Europäischen Raum - Vorbereitung der Audits inklusive Reiseorganisation - Durchführung von Qualifizierungsaudits bei Plasmalieferanten / Dienstleistern nach GxP im Europäischen Raum, - Überprüfung der Compliance im Hinblick auf regulatorische und gesetzliche Vorgaben - Evaluierung der Auditergebnisse, Durchführung von Risikoanalysen und Bewertung der Auswirkungen auf den Qualifizierungsstatus des Plasmalieferanten / Dienstleisters; Bewertung der korrektiven / präventiven MaßnahmenIhr Profil: - Erfolgreich abgeschlossene Berufsausbildung oder abgeschlossenes Bachelorstudium im Gesundheitswesen oder im naturwissenschaftlichen Bereich; 2 – 3 Jahre Berufserfahrung wünschenswert; - Fundierte Kenntnisse im Qualitätsmanagement und GxP-Bereich sowie Audit-/Inspektionserfahrung von Vorteil; - Sicherer Umgang mit MS-Office-Standardsoftware; - Bereitschaft zu intensiver Reisetätigkeit mit einem hohen Maß an Flexibilität; - Analytisches und lösungsorientiertes Denkvermögen sowie strukturierte und selbständige Arbeitsweise; - Team- und Konfliktfähigkeit sowie sehr gute Umgangsformen; - Weitere Fremdsprachenkenntnisse wünschenswert; Ihre Benefits: - Eine betriebliche Spezial-Ausbildung zum GxP-Auditor; - Möglichkeiten zur persönlichen und beruflichen Weiterentwicklung; - Abwechslungsreiches sowie anspruchs- und verantwortungsvolles Aufgabengebiet; - Angenehme Arbeitsatmosphäre in einem internationalen, dynamischen und leistungsstarken Team; - Eine attraktive Vergütung mit zusätzlicher Altersversorgung; Ihre aussagekräftige Bewerbung richten Sie bitte an: CSL Plasma GmbH, PSCQ_SQ, Ute Cherfan, Weender Strasse 75 in 37073 Göttingen oder per Email an ute.cherfan@cslplasma.com Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSL PlasmaCSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma. We want CSL to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Plasma!

Job Description Summary This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations. • Reporting compliance status data to operational quality management • Collaborate with center management in the development and implementation of continuous improvement plans • Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during internal and external audits, responds to questions, and may stop operations, including shipments to address quality concerns • Responsible for coordinating and managing training activities, policies and processes at the center level ​Job Description 1 Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications. 2 Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 3 Perform center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 4 Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements. 5 Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards. 6 Initiates schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements. Ensure the most current version of training materials at the center is being used 7 Collaborates with center management when viewing the Quality Management System to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues. 8 Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management. 9 Identifying and communicate non-conformities to CSL’s SOP’s. In the absence of the AQM, may conduct monthly quality team meeting to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation. 10 Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center. 11 Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers. 12 Responsible to initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective. 13 Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable. 14 Follow all Standard Operating Procedures (SOPs), company policies and procedures. 15 Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA. 16 Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable. 17 Assist Plasma center staff in completing other special projects or assignments, as requested. 18 Perform other job-related duties, as assigned. Education • High school diploma or equivalent required. Associate or Bachelor’s degree in business administration or biological sciences preferred. Experience • Minimum 1-year leadership experience or equivalent of one-year experience in a regulated environment. • Strong customer service skills • Strong critical reasoning, decision-making and problem solving skills to analyze situations • Organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives • Understand Quality Systems and/or regulated training requirements Working Conditions (physical & mental requirements) • Occasionally required to work with the public when they are dissatisfied • 80% of the time standing and walking and 20% of the time sitting • Reach, bend, kneel and have high level of manual dexterity • See and speak with customers and observe equipment operation • Occasionally be required to lift and carry 25 lbs. • Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications. #CB #CB CSL offers the following benefits for this full-time position, most are effective the first day of hire: Options for health care benefits, including choices of plans for medical and prescription drug, dental, and vision coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSL’s 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company. Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSL PlasmaCSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Plasma!

Job Description Summary This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations. • Reporting compliance status data to operational quality management • Collaborate with center management in the development and implementation of continuous improvement plans • Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during internal and external audits, responds to questions, and may stop operations, including shipments to address quality concerns • Responsible for coordinating and managing training activities, policies and processes at the center level ​Job Description 1 Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications. 2 Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 3 Perform center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 4 Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements. 5 Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards. 6 Initiates schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements. Ensure the most current version of training materials at the center is being used 7 Collaborates with center management when viewing the Quality Management System to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues. 8 Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management. 9 Identifying and communicate non-conformities to CSL’s SOP’s. In the absence of the AQM, may conduct monthly quality team meeting to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation. 10 Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center. 11 Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers. 12 Responsible to initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective. 13 Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable. 14 Follow all Standard Operating Procedures (SOPs), company policies and procedures. 15 Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA. 16 Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable. 17 Assist Plasma center staff in completing other special projects or assignments, as requested. 18 Perform other job-related duties, as assigned. Education • High school diploma or equivalent required. Associate or Bachelor’s degree in business administration or biological sciences preferred. Experience • Minimum 1-year leadership experience or equivalent of one-year experience in a regulated environment. • Strong customer service skills • Strong critical reasoning, decision-making and problem solving skills to analyze situations • Organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives • Understand Quality Systems and/or regulated training requirements Working Conditions (physical & mental requirements) • Occasionally required to work with the public when they are dissatisfied • 80% of the time standing and walking and 20% of the time sitting • Reach, bend, kneel and have high level of manual dexterity • See and speak with customers and observe equipment operation • Occasionally be required to lift and carry 25 lbs. • Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications. #CB #CB CSL offers the following benefits for this full-time position, most are effective the first day of hire: Options for health care benefits, including choices of plans for medical and prescription drug, dental, and vision coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSL’s 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company. Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSL PlasmaCSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Plasma!

Job Description Summary This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations. • Reporting compliance status data to operational quality management • Collaborate with center management in the development and implementation of continuous improvement plans • Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during internal and external audits, responds to questions, and may stop operations, including shipments to address quality concerns • Responsible for coordinating and managing training activities, policies and processes at the center level ​Job Description 1 Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications. 2 Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 3 Perform center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 4 Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements. 5 Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards. 6 Initiates schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements. Ensure the most current version of training materials at the center is being used 7 Collaborates with center management when viewing the Quality Management System to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues. 8 Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management. 9 Identifying and communicate non-conformities to CSL’s SOP’s. In the absence of the AQM, may conduct monthly quality team meeting to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation. 10 Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center. 11 Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers. 12 Responsible to initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective. 13 Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable. 14 Follow all Standard Operating Procedures (SOPs), company policies and procedures. 15 Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA. 16 Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable. 17 Assist Plasma center staff in completing other special projects or assignments, as requested. 18 Perform other job-related duties, as assigned. Education • High school diploma or equivalent required. Associate or Bachelor’s degree in business administration or biological sciences preferred. Experience • Minimum 1-year leadership experience or equivalent of one-year experience in a regulated environment. • Strong customer service skills • Strong critical reasoning, decision-making and problem solving skills to analyze situations • Organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives • Understand Quality Systems and/or regulated training requirements Working Conditions (physical & mental requirements) • Occasionally required to work with the public when they are dissatisfied • 80% of the time standing and walking and 20% of the time sitting • Reach, bend, kneel and have high level of manual dexterity • See and speak with customers and observe equipment operation • Occasionally be required to lift and carry 25 lbs. • Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications. #CB CSL offers the following benefits for this full-time position, most are effective the first day of hire: Options for health care benefits, including choices of plans for medical and prescription drug, dental, and vision coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSL’s 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company. Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSL PlasmaCSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Plasma!

Job Description Summary This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations. • Reporting compliance status data to operational quality management • Collaborate with center management in the development and implementation of continuous improvement plans • Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during internal and external audits, responds to questions, and may stop operations, including shipments to address quality concerns • Responsible for coordinating and managing training activities, policies and processes at the center level ​Job Description 1 Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications. 2 Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 3 Perform center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 4 Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements. 5 Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards. 6 Initiates schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements. Ensure the most current version of training materials at the center is being used 7 Collaborates with center management when viewing the Quality Management System to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues. 8 Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management. 9 Identifying and communicate non-conformities to CSL’s SOP’s. In the absence of the AQM, may conduct monthly quality team meeting to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation. 10 Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center. 11 Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers. 12 Responsible to initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective. 13 Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable. 14 Follow all Standard Operating Procedures (SOPs), company policies and procedures. 15 Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA. 16 Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable. 17 Assist Plasma center staff in completing other special projects or assignments, as requested. 18 Perform other job-related duties, as assigned. Education • High school diploma or equivalent required. Associate or Bachelor’s degree in business administration or biological sciences preferred. Experience • Minimum 1-year leadership experience or equivalent of one-year experience in a regulated environment. • Strong customer service skills • Strong critical reasoning, decision-making and problem solving skills to analyze situations • Organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives • Understand Quality Systems and/or regulated training requirements Working Conditions (physical & mental requirements) • Occasionally required to work with the public when they are dissatisfied • 80% of the time standing and walking and 20% of the time sitting • Reach, bend, kneel and have high level of manual dexterity • See and speak with customers and observe equipment operation • Occasionally be required to lift and carry 25 lbs. • Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications. #CB CSL offers the following benefits for this full-time position, most are effective the first day of hire: Options for health care benefits, including choices of plans for medical and prescription drug, dental, and vision coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSL’s 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company. Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSL PlasmaCSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Plasma!

Job Description Summary This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations. • Reporting compliance status data to operational quality management • Collaborate with center management in the development and implementation of continuous improvement plans • Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during internal and external audits, responds to questions, and may stop operations, including shipments to address quality concerns • Responsible for coordinating and managing training activities, policies and processes at the center level ​Job Description 1 Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications. 2 Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 3 Perform center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 4 Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements. 5 Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards. 6 Initiates schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements. Ensure the most current version of training materials at the center is being used 7 Collaborates with center management when viewing the Quality Management System to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues. 8 Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management. 9 Identifying and communicate non-conformities to CSL’s SOP’s. In the absence of the AQM, may conduct monthly quality team meeting to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation. 10 Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center. 11 Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers. 12 Responsible to initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective. 13 Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable. 14 Follow all Standard Operating Procedures (SOPs), company policies and procedures. 15 Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA. 16 Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable. 17 Assist Plasma center staff in completing other special projects or assignments, as requested. 18 Perform other job-related duties, as assigned. Education • High school diploma or equivalent required. Associate or Bachelor’s degree in business administration or biological sciences preferred. Experience • Minimum 1-year leadership experience or equivalent of one-year experience in a regulated environment. • Strong customer service skills • Strong critical reasoning, decision-making and problem solving skills to analyze situations • Organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives • Understand Quality Systems and/or regulated training requirements Working Conditions (physical & mental requirements) • Occasionally required to work with the public when they are dissatisfied • 80% of the time standing and walking and 20% of the time sitting • Reach, bend, kneel and have high level of manual dexterity • See and speak with customers and observe equipment operation • Occasionally be required to lift and carry 25 lbs. • Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications. #CB #CB CSL offers the following benefits for this full-time position, most are effective the first day of hire: Options for health care benefits, including choices of plans for medical and prescription drug, dental, and vision coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSL’s 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company. Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSL PlasmaCSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Plasma!

CSL Plasma ist eines der weltweit größten Unternehmen zur Gewinnung von Humanplasma für die Herstellung von hochwirksamen Gerinnungs- und Immunglobulin-Präparaten. Als ein Unternehmen der CSL Behring Gruppe, einem der weltweit größten Anbieter von lebensrettenden Biotherapeutika, ist CSL Plasma für Gewinnung, Lagerung und Testung von Plasma zuständig. Wichtig für den reibungslosen Ablauf sind nicht nur Qualität, Sicherheit und modernste Technik, sondern vor allem unsere qualifizierten und motivierten Mitarbeitenden, die dazu beitragen, die gesetzten Ziele erfolgreich umzusetzen. Für unsere Abteilung Quality Assurance Göttingen suchen wir ab sofort in Vollzeit (zunächst befristet) einen Berufseinsteiger (m/w/d) zur Weiterbildung als Auditor/in mit sehr guten Sprachkenntnissen in Deutsch und Englisch sowie Italienisch und/oder Französisch und/oder Spanisch Ihre Tätigkeiten nach Weiterbildung zum Auditor (m/w/d): · Durchführung von Qualifizierungsaudits in der jeweiligen Landessprache (DE/EN/IT/FR/ES) im Raum EMEA bei Plasmalieferanten / Dienstleistern nach GxP und DIN ISO und Evaluierung der Auditergebnisse, · Durchführung von Risikoanalysen und Bewertung der Auswirkungen auf den Qualifizierungsstatus des Plasmalieferanten / Dienstleisters; Bewertung der korrektiven / präventiven Maßnahmen; · Überprüfung der Umsetzung und Einhaltung von Regularien und der CSL Qualitätsanforderungen für alle zu auditierenden Einrichtungen; · Unterstützung bei der Weiterentwicklung der etablierten Auditsysteme; · Unterstützung bei Erstellung und Bearbeitung von Standard-Arbeitsanweisungen; · Aktualisierung verschiedener Arbeitslisten zur tagesaktuellen Bereitstellung von Kennzahlen; · Elektronische Erfassung und Bearbeitung von Abweichungsmeldungen; · Mitwirkung bei der Durchführung von Trainings und Workshops Ihr Profil: · Erfolgreich abgeschlossene Berufsausbildung oder abgeschlossenes Bachelorstudium im Gesundheitswesen, Bereich Medizinprodukte oder im naturwissenschaftlichen Bereich; · Kenntnisse in Deutsch und Englisch, in Wort und Schrift (verhandlungssicher) · Weitere Fremdsprachen erforderlich wie z. B. Italienisch, Französisch und/oder Spanisch (verhandlungssicher) · Bereitschaft zu intensiver Reisetätigkeit mit einem hohen Maß an Flexibilität; · Analytisches und lösungsorientiertes Denkvermögen sowie strukturierte und selbständige Arbeitsweise; · Fähigkeit zur Beurteilung und Interpretation von komplexen Regularien · Team- und Konfliktfähigkeit sowie ausgeprägte persönliche und soziale Kompetenz; Sicherer Umgang mit MS-Office-Standardsoftware; Ihre Benefits: · Weiterbildung im Bereich GxP-Auditor; · Möglichkeiten zur persönlichen und beruflichen Weiterentwicklung; · Abwechslungsreiches sowie anspruchs- und verantwortungsvolles Aufgabengebiet; · Angenehme Arbeitsatmosphäre in einem internationalen, dynamischen und leistungsstarken Team; · Eine attraktive Vergütung mit zusätzlicher Altersversorgung. Ihre aussagekräftige Bewerbung richten Sie bitte an: CSL Plasma GmbH, QA_SQ EMEA, Ute Cherfan, Weender Strasse 75 in 37073 Göttingen oder per Email an ute.cherfan@cslplasma.com Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSL PlasmaCSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma. We want CSL to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Plasma!

Job Description Summary This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations. • Reporting compliance status data to operational quality management • Collaborate with center management in the development and implementation of continuous improvement plans • Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during internal and external audits, responds to questions, and may stop operations, including shipments to address quality concerns • Responsible for coordinating and managing training activities, policies and processes at the center level ​Job Description 1 Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications. 2 Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 3 Perform center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 4 Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements. 5 Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards. 6 Initiates schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements. Ensure the most current version of training materials at the center is being used 7 Collaborates with center management when viewing the Quality Management System to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues. 8 Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management. 9 Identifying and communicate non-conformities to CSL’s SOP’s. In the absence of the AQM, may conduct monthly quality team meeting to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation. 10 Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center. 11 Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers. 12 Responsible to initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective. 13 Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable. 14 Follow all Standard Operating Procedures (SOPs), company policies and procedures. 15 Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA. 16 Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable. 17 Assist Plasma center staff in completing other special projects or assignments, as requested. 18 Perform other job-related duties, as assigned. Education • High school diploma or equivalent required. Associate or Bachelor’s degree in business administration or biological sciences preferred. Experience • Minimum 1-year leadership experience or equivalent of one-year experience in a regulated environment. • Strong customer service skills • Strong critical reasoning, decision-making and problem solving skills to analyze situations • Organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives • Understand Quality Systems and/or regulated training requirements Working Conditions (physical & mental requirements) • Occasionally required to work with the public when they are dissatisfied • 80% of the time standing and walking and 20% of the time sitting • Reach, bend, kneel and have high level of manual dexterity • See and speak with customers and observe equipment operation • Occasionally be required to lift and carry 25 lbs. • Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications. #CB #CB CSL offers the following benefits for this full-time position, most are effective the first day of hire: Options for health care benefits, including choices of plans for medical and prescription drug, dental, and vision coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSL’s 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company. Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSL PlasmaCSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Plasma!

Job Description Summary This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations. • Reporting compliance status data to operational quality management • Collaborate with center management in the development and implementation of continuous improvement plans • Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during internal and external audits, responds to questions, and may stop operations, including shipments to address quality concerns • Responsible for coordinating and managing training activities, policies and processes at the center level ​Job Description 1 Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications. 2 Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 3 Perform center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 4 Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements. 5 Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards. 6 Initiates schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements. Ensure the most current version of training materials at the center is being used 7 Collaborates with center management when viewing the Quality Management System to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues. 8 Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management. 9 Identifying and communicate non-conformities to CSL’s SOP’s. In the absence of the AQM, may conduct monthly quality team meeting to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation. 10 Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center. 11 Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers. 12 Responsible to initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective. 13 Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable. 14 Follow all Standard Operating Procedures (SOPs), company policies and procedures. 15 Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA. 16 Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable. 17 Assist Plasma center staff in completing other special projects or assignments, as requested. 18 Perform other job-related duties, as assigned. Education • High school diploma or equivalent required. Associate or Bachelor’s degree in business administration or biological sciences preferred. Experience • Minimum 1-year leadership experience or equivalent of one-year experience in a regulated environment. • Strong customer service skills • Strong critical reasoning, decision-making and problem solving skills to analyze situations • Organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives • Understand Quality Systems and/or regulated training requirements Working Conditions (physical & mental requirements) • Occasionally required to work with the public when they are dissatisfied • 80% of the time standing and walking and 20% of the time sitting • Reach, bend, kneel and have high level of manual dexterity • See and speak with customers and observe equipment operation • Occasionally be required to lift and carry 25 lbs. • Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications. #CB #CB CSL offers the following benefits for this full-time position, most are effective the first day of hire: Options for health care benefits, including choices of plans for medical and prescription drug, dental, and vision coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSL’s 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company. Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSLCSL is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives through innovation. Learn more about CSL. We want CSL to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL!

Job Description Summary This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations. • Reporting compliance status data to operational quality management • Collaborate with center management in the development and implementation of continuous improvement plans • Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during internal and external audits, responds to questions, and may stop operations, including shipments to address quality concerns • Responsible for coordinating and managing training activities, policies and processes at the center level ​Job Description 1 Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications. 2 Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 3 Perform center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 4 Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements. 5 Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards. 6 Initiates schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements. Ensure the most current version of training materials at the center is being used 7 Collaborates with center management when viewing the Quality Management System to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues. 8 Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management. 9 Identifying and communicate non-conformities to CSL’s SOP’s. In the absence of the AQM, may conduct monthly quality team meeting to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation. 10 Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center. 11 Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers. 12 Responsible to initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective. 13 Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable. 14 Follow all Standard Operating Procedures (SOPs), company policies and procedures. 15 Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA. 16 Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable. 17 Assist Plasma center staff in completing other special projects or assignments, as requested. 18 Perform other job-related duties, as assigned. Education • High school diploma or equivalent required. Associate or Bachelor’s degree in business administration or biological sciences preferred. Experience • Minimum 1-year leadership experience or equivalent of one-year experience in a regulated environment. • Strong customer service skills • Strong critical reasoning, decision-making and problem solving skills to analyze situations • Organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives • Understand Quality Systems and/or regulated training requirements Working Conditions (physical & mental requirements) • Occasionally required to work with the public when they are dissatisfied • 80% of the time standing and walking and 20% of the time sitting • Reach, bend, kneel and have high level of manual dexterity • See and speak with customers and observe equipment operation • Occasionally be required to lift and carry 25 lbs. • Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications. #CB #CB CSL offers the following benefits for this full-time position, most are effective the first day of hire: Options for health care benefits, including choices of plans for medical and prescription drug, dental, and vision coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSL’s 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company. Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSLCSL is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives through innovation. Learn more about CSL. We want CSL to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL!

Job Description Summary This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations. • Reporting compliance status data to operational quality management • Collaborate with center management in the development and implementation of continuous improvement plans • Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during internal and external audits, responds to questions, and may stop operations, including shipments to address quality concerns • Responsible for coordinating and managing training activities, policies and processes at the center level ​Job Description 1 Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications. 2 Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 3 Perform center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 4 Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements. 5 Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards. 6 Initiates schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements. Ensure the most current version of training materials at the center is being used 7 Collaborates with center management when viewing the Quality Management System to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues. 8 Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management. 9 Identifying and communicate non-conformities to CSL’s SOP’s. In the absence of the AQM, may conduct monthly quality team meeting to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation. 10 Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center. 11 Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers. 12 Responsible to initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective. 13 Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable. 14 Follow all Standard Operating Procedures (SOPs), company policies and procedures. 15 Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA. 16 Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable. 17 Assist Plasma center staff in completing other special projects or assignments, as requested. 18 Perform other job-related duties, as assigned. Education • High school diploma or equivalent required. Associate or Bachelor’s degree in business administration or biological sciences preferred. Experience • Minimum 1-year leadership experience or equivalent of one-year experience in a regulated environment. • Strong customer service skills • Strong critical reasoning, decision-making and problem solving skills to analyze situations • Organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives • Understand Quality Systems and/or regulated training requirements Working Conditions (physical & mental requirements) • Occasionally required to work with the public when they are dissatisfied • 80% of the time standing and walking and 20% of the time sitting • Reach, bend, kneel and have high level of manual dexterity • See and speak with customers and observe equipment operation • Occasionally be required to lift and carry 25 lbs. • Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications. #CB #CB CSL offers the following benefits for this full-time position, most are effective the first day of hire: Options for health care benefits, including choices of plans for medical and prescription drug, dental, and vision coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSL’s 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company. Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSLCSL is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives through innovation. Learn more about CSL. We want CSL to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL!

The OpportunityYou will ensure regulatory compliance to GLP, ISO/IEC 17025, GCLP, GRLP activities and other GxP requirements (as applicable) for CSL in the EU. You will develop inspection readiness activities, manage the ongoing requirements for GLP/GCLP R&D Quality Systems, and R&D Quality and lead quality projects and taskforces as they arise from different sources and issues. The RoleProvide guidance in GLP, GCLP, GRLP & GxP best practices to ensure that R&D employees are aware of quality requirementsEnsure regulatory compliance with OECD Principles of Good Laboratory Practice (GLP) and ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories.Manage GLP/GCLP QS for EU ensuring procedures are in line with Global R&D Quality.Primary representative for R&D Quality on site quality management forums and discussions (EU)Develop phase appropriate quality systemsPrimary EU representative for GLP/GCLP for Change Control Panel (as required)Track and trend R&D Quality Measurements for GLP/GCLP EUApply GLP/GCLP Management System for Research, Pre-Clinical and Clinical Phases (I/II/III) where appropriateDevelop and implement inspection readiness programmes ensuring consistency across programs and regionsMaintain the execution of inspections following the GLP and ISO 17025 Inspection (inc. GRLP) Schedule as it applies to relevant departmentsConduct ISO 17025 inspections and GLP process inspections, facility inspections, study inspections and document inspections to determine if all studies are conducted in compliance with the OECD Principles of GLP; report inspections findings and improvement recommendations to relevant departmentsEnsure all inspection findings are reported to Test/Site Facility Management and Study Director and Principal Investigator as applicable to relevant departments for Plasma and Recombinant Product Development and Gene TherapiesHost external GLP and GCLP (ISO/IEC 17025) regulatory inspectionsManagement of Corrective and Preventive Actions (CAPA) for compliant responses to findings and their closeout· Track and trend finding responses for GLP and GCLP (ISO/IEC 17025) regulatory inspectionsSupport Global Research and Clinical Pharmacology and Translation Development and provide assurance to the company that the regulated and non-regulated scientific research or early phase non-clinical and clinical activities undertaken comply with applicable regulatory requirements, relevant industry standards and company policies and SOPsSupport the GLP/GCLP vendor audit programme for GLP/GCLP by performing audits in theSupport R&D partners with change, deviation and CAPA management· Facilitate GxP assessments for R&D equipment and facilitiesHelp develop global Quality Management Review for GLP/GCLP and Early Development Process control stream· Build business relationships with local and global R&D Quality sites to ensure agreement on quality inspectionsEducate and inform R&D on international trends in quality and compliance in the pharmaceutical industry as they relate to biotechnology product development· Partners with the R&D Quality LT and Head of R&D Quality Management Systems to establish appropriate QMS framework and GxP appropriate proceduresMentor team members to provide support across the site to ensure compliance with regulatory requirement and global policiesParticipate in continuous improvement activities including global harmonisation projects.Support projects and new system implementations Your skills and experienceDegree in relevant biological science 10+ years experience in one of the following: R&D Quality (GLP and/or GCLP) Influencing key stakeholders related to inspection readiness and compliance with regulations Knowledge of OECD Principles of GLP Knowledge of ISO/IEC 17025 – Testing and Calibration Laboratory Requirements Experience and knowledge in the application of Quality Systems Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring. We want CSL to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!

Responsibilities: • Under general direction, monitors plasma center processes to ensure compliance with Standard Operating Procedures (SOPs) and applicable local, state and federal requirements • Partners with management to have the center “inspection ready” at all times by managing compliance to SOPs and the quality system • Ensures compliance to quality processes, regulatory requirements, SOPs and necessary training for plasma center and business operations • Coordinates training and facilitates processes to support timely reporting of biologic product deviations to Food & Drug Administration (FDA) • Performs/ensures center records quality review to ensure thoroughness, accuracy and timeliness of required information • Initiates investigation to ensure documentation of deficiencies and development of corrective action plans, in partnership with management • Ensures training materials/documents are maintained and modified regularly; maintains the Learning Management System to ensure data integrity, report generation and data analysis • Leads internal audits to monitor facility compliance with SOPs, cGMP, OHSA, FDA, and other regulations, as applicable Qualifications: • Bachelor’s/Associate degree in business administration or biological sciences preferred, or equivalent combination of education, training and experience • 3-5 years’ experience in quality within Plasma or related industry • Minimum 1-year supervisory/leadership experience or equivalent of 1-year experience in a regulated environment • Knowledge of cGMP, OHSA, FDA, and other applicable regulations • Strong customer service skills • Equivalent combination of education and professional work experience required Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable. Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSL PlasmaCSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Plasma!

Für die Abteilung QA Lieferantenqualifizierung in Göttingen suchen wir ab sofort einen Manager Supplier Qualification (Auditing) EMEA (m/w/d) (Vollzeit / unbefristet) Ihre Tätigkeiten: · Ansprechpartner für die Auditoren im Verantwortungsbereich zur Unterstützung in allen Fragen der Lieferantenqualifizierung. · Überwachung der Einhaltung der CSL Produktspezifikationen und Qualitätsanforderungen bei Plasmalieferanten/Zulieferern/Dienstleistern. · Verantwortlich für die Planung und Sicherstellung der erforderlichen Qualifizierungen für Plasmalieferanten/Zulieferern/ Dienstleistern. · Prüfung, Bewertung und Genehmigung von Auditberichten. · Erstellung, Prüfung und Genehmigung von komplexen Risikoanalysen. · Fortlaufende Betreuung und Weiterentwicklung des internen/externen Auditprozesses im globalen Kontext. · Sicherstellung der Quality-Oversight gemäß den gültigen Standardarbeitsanweisungen (SOPs). · Erstellen bzw. Prüfen von Änderungsanträgen (Change Control) · Bearbeitung, Koordination bzw. Bewertung und Genehmigung von Abweichungen im Verantwortungsbereich. · Evaluierung, Abstimmung und Umsetzung von komplexen CAPAs zur Vermeidung wiederkehrender Abweichungen. · Entwicklung, Erhebung, Auswertung und Bereitstellung von Leistungskennzahlen (KPIs) zur Überwachung von Prozessen innerhalb des Verantwortungsbereiches. · Bereitschaft zu Dienstreisen in Zusammenhang mit dem Verantwortungsbereich. Ihr Profil: Abgeschlossenes naturwissenschaftliches Studium oder alternativ abgeschlossene Berufsausbildung im Gesundheitswesen. Mindestens 3 - 5-jährige Erfahrung im GxP-Bereich in der pharmazeutischen Industrie. Langjährige Leitungserfahrung mit der Fähigkeit, ein leistungsstarkes Team aufzubauen, zu betreuen und zu fördern. Fähigkeit, andere zu überzeugen, zu motivieren und gleichzeitig ein kohärentes Teamumfeld zu schaffen. Mehrjährige Erfahrung im Qualitätssicherungsbereich, einschließlich fundierter Kenntnisse als Auditor. Sehr gute Ausdrucksweise in Wort und Schrift in Deutsch und Englisch (verhandlungssicher); weitere Sprachkenntnisse sind von Vorteil. Analytisches und vorausschauendes Denkvermögen sowie ausgeprägtes Verständnis für Zahlen. Fähigkeit zur Beurteilung und Interpretation von komplexen Regularien. Organisationstalent (Fähigkeit zur Selbst- und Arbeitsorganisation) sowie Eigeninitiative. Effektive Präsentations- und Kommunikationsfähigkeiten auf allen Ebenen der Organisation und gegenüber externen Kollegen, Mitarbeitern und Lieferanten. Ihre Benefits: · Abwechslungsreiches sowie anspruchs- und verantwortungsvolles Aufgabengebiet; · Angenehme Arbeitsatmosphäre in einem internationalen, dynamischen und leistungsstarken Team; · Möglichkeiten zur persönlichen und beruflichen Weiterentwicklung; · Eine attraktive Vergütung mit zusätzlicher Altersversorgung. Ihre aussagekräftige Bewerbung richten Sie bitte an: CSL Plasma GmbH, QA_SQ EMEA, Ute Cherfan, Weender Strasse 75 in 37073 Göttingen oder per Email an ute.cherfan@cslplasma.com Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSL PlasmaCSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma. We want CSL to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Plasma!

Für die Abteilung Qualitätssicherung CSL Plasma in Göttingen suchen wir ab sofort einen Quality Expert EMEA / Sachbearbeiter in der Qualitätssicherung (m/w/d) mit Sprachkenntnissen in Deutsch, Englisch und Italienisch (verhandlungssicher) (Vollzeit/befristet für 2 Jahre mit dem Ziel der Entfristung) Ihre Tätigkeiten: Betreuung und Überwachung unserer Plasmalieferanten in Europa, Mittleren Osten und Afrika (EMEA). Ansprechpartner für alle Lieferanten in Bezug auf qualitätsrelevante Anfragen. Schriftliche Korrespondenz innerhalb und außerhalb der CSL Organisation. Erhebung und Aufbereitung von Daten für die Europäische Zulassungsbehörde. Erfassen und Beurteilen von Änderungs-/Abweichungsmeldungen/Beanstandungen im elektronischen Qualitätsmanagement System Durchführung von Risikoanalysen im Zusammenhang mit Änderungs-/Abweichungsmeldungen sowie Beanstandungen. Durchführung von Wirksamkeitsprüfungen implementierter korrektiver und präventiver Maßnahmen. Erhebung sowie Aufbereitung von qualitätsrelevanten Kennzahlen zur Lieferantenbewertung. Zusammenarbeit mit Fachabteilungen innerhalb der globalen CSL Organisation. Ihr Profil: Abgeschlossenes Bachelorstudium in Business Administration oder Naturwissenschaften Sehr gute Ausdrucksweise in Wort und Schrift in Deutsch, Englisch und Italienisch Hohes Qualitätsbewusstsein als Voraussetzung für GxP-gerechtes Arbeiten Analytisches und vorausschauendes Denkvermögen. Selbständiges und strukturiertes Arbeiten Ausgeprägte Kommunikations- und Motivationsfähigkeit sowie Flexibilität Teamfähigkeit und gute Umgangsformen Sehr gute EDV-Kenntnisse erforderlich Ihre aussagekräftige Bewerbung richten Sie bitte an: CSL Plasma GmbH, QA_SQ EMEA, Ute Cherfan, Weender Strasse 75 in 37073 Göttingen oder per Email an ute.cherfan@cslplasma.com Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSL PlasmaCSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma. We want CSL to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Plasma!

Job Description Summary This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations. • Reporting compliance status data to operational quality management • Collaborate with center management in the development and implementation of continuous improvement plans • Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during internal and external audits, responds to questions, and may stop operations, including shipments to address quality concerns • Responsible for coordinating and managing training activities, policies and processes at the center level ​Job Description 1 Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications. 2 Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 3 Perform center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 4 Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements. 5 Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards. 6 Initiates schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements. Ensure the most current version of training materials at the center is being used 7 Collaborates with center management when viewing the Quality Management System to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues. 8 Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management. 9 Identifying and communicate non-conformities to CSL’s SOP’s. In the absence of the AQM, may conduct monthly quality team meeting to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation. 10 Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center. 11 Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers. 12 Responsible to initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective. 13 Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable. 14 Follow all Standard Operating Procedures (SOPs), company policies and procedures. 15 Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA. 16 Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable. 17 Assist Plasma center staff in completing other special projects or assignments, as requested. 18 Perform other job-related duties, as assigned. Education • High school diploma or equivalent required. Associate or Bachelor’s degree in business administration or biological sciences preferred. Experience • Minimum 1-year leadership experience or equivalent of one-year experience in a regulated environment. • Strong customer service skills • Strong critical reasoning, decision-making and problem solving skills to analyze situations • Organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives • Understand Quality Systems and/or regulated training requirements Working Conditions (physical & mental requirements) • Occasionally required to work with the public when they are dissatisfied • 80% of the time standing and walking and 20% of the time sitting • Reach, bend, kneel and have high level of manual dexterity • See and speak with customers and observe equipment operation • Occasionally be required to lift and carry 25 lbs. • Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications. #CB CSL offers the following benefits for this full-time position, most are effective the first day of hire: Options for health care benefits, including choices of plans for medical and prescription drug, dental, and vision coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSL’s 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company. Our BenefitsCSL offers the following benefits for this full-time position: Options for health care benefits, including choices of plans for medical, dental, and vision, prescription drug coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSL’s 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company. For more information on CSL Plasma benefits visit https://cslbenefits.com/cslp. About CSL PlasmaCSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Plasma!

Job Description Summary This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations. • Reporting compliance status data to operational quality management • Collaborate with center management in the development and implementation of continuous improvement plans • Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during internal and external audits, responds to questions, and may stop operations, including shipments to address quality concerns • Responsible for coordinating and managing training activities, policies and processes at the center level ​Job Description 1 Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications. 2 Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 3 Perform center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 4 Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements. 5 Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards. 6 Initiates schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements. Ensure the most current version of training materials at the center is being used 7 Collaborates with center management when viewing the Quality Management System to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues. 8 Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management. 9 Identifying and communicate non-conformities to CSL’s SOP’s. In the absence of the AQM, may conduct monthly quality team meeting to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation. 10 Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center. 11 Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers. 12 Responsible to initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective. 13 Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable. 14 Follow all Standard Operating Procedures (SOPs), company policies and procedures. 15 Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA. 16 Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable. 17 Assist Plasma center staff in completing other special projects or assignments, as requested. 18 Perform other job-related duties, as assigned. Education • High school diploma or equivalent required. Associate or Bachelor’s degree in business administration or biological sciences preferred. Experience • Minimum 1-year leadership experience or equivalent of one-year experience in a regulated environment. • Strong customer service skills • Strong critical reasoning, decision-making and problem solving skills to analyze situations • Organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives • Understand Quality Systems and/or regulated training requirements Working Conditions (physical & mental requirements) • Occasionally required to work with the public when they are dissatisfied • 80% of the time standing and walking and 20% of the time sitting • Reach, bend, kneel and have high level of manual dexterity • See and speak with customers and observe equipment operation • Occasionally be required to lift and carry 25 lbs. • Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications. #CB Please note, we may not have an immediate need at the present time; however we are always interested in speaking to well qualified candidates for future openings. If you are interested in exploring a career with CSL, please apply. Someone will follow up depending on the current needs, but please be aware correspondence may not be immediate. CSL offers the following benefits for this full-time position, most are effective the first day of hire: Options for health care benefits, including choices of plans for medical and prescription drug, dental, and vision coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSL’s 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company. Our BenefitsCSL offers the following benefits for this full-time position: Options for health care benefits, including choices of plans for medical, dental, and vision, prescription drug coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSL’s 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company. For more information on CSL Plasma benefits visit https://cslbenefits.com/cslp. About CSL PlasmaCSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Plasma!