CSL

Responsibilities: • Under limited supervision, assists in carrying out production-related tests and inspections to control quality • Follows established procedures to check, test and inspect raw materials, intermediates or finished products • Properly documents test results in appropriate records and computer system • Supports documentation and records, distributing, and filing all manufacturing procedures, deviations, etc. • Follows Standard Operating Procedures (SOPs) and maintains compliance to current Good Manufacturing Practice (cGMP) regulatory guidelines Qualifications: • High School Diploma or equivalent vocational or technical training; Associate's degree in a relevant scientific discipline preferred • 1-2 years' related pharmaceutical experience including experience in a regulated environment • Knowledge of cGMP standards • Proficiency in Microsoft Office and QC systems Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable. 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!

The Opportunity 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 managementCollaborate with center management in the development and implementation of continuous improvement plansCollaborate 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 concernsResponsible for coordinating and managing training activities, policies and processes at the center level. You will report to the Assistant Manager Quality The Role Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications.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.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.Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements.Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards.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 usedCollaborates 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.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.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.Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center.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.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.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.Follow all Standard Operating Procedures (SOPs), company policies and procedures.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.Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable.Assist Plasma center staff in completing other special projects or assignments, as requested.Perform other job-related duties, as assigned.dd 4-6 key responsibilities of the job Your skills and experience 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 skillsStrong critical reasoning, decision-making and problem solving skills to analyze situationsOrganizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectivesUnderstand Quality Systems and/or regulated training requirements Working Conditions (physical & mental requirements) Occasionally required to work with the public when they are dissatisfied80% of the time standing and walking and 20% of the time sittingReach, bend, kneel and have high level of manual dexteritySee and speak with customers and observe equipment operationOccasionally be required to lift and carry 25 lbs.Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors 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!

The Opportunity 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 managementCollaborate with center management in the development and implementation of continuous improvement plansCollaborate 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 concernsResponsible for coordinating and managing training activities, policies and processes at the center level. You will report to the Assistant Manager Quality The Role Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications.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.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.Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements.Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards.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 usedCollaborates 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.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.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.Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center.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.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.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.Follow all Standard Operating Procedures (SOPs), company policies and procedures.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.Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable.Assist Plasma center staff in completing other special projects or assignments, as requested.Perform other job-related duties, as assigned.dd 4-6 key responsibilities of the job Your skills and experience 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 skillsStrong critical reasoning, decision-making and problem solving skills to analyze situationsOrganizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectivesUnderstand Quality Systems and/or regulated training requirements Working Conditions (physical & mental requirements) Occasionally required to work with the public when they are dissatisfied80% of the time standing and walking and 20% of the time sittingReach, bend, kneel and have high level of manual dexteritySee and speak with customers and observe equipment operationOccasionally be required to lift and carry 25 lbs.Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors 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!

The Opportunity 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 managementCollaborate with center management in the development and implementation of continuous improvement plansCollaborate 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 concernsResponsible for coordinating and managing training activities, policies and processes at the center level. You will report to the Assistant Manager Quality The Role Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications.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.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.Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements.Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards.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 usedCollaborates 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.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.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.Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center.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.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.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.Follow all Standard Operating Procedures (SOPs), company policies and procedures.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.Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable.Assist Plasma center staff in completing other special projects or assignments, as requested.Perform other job-related duties, as assigned.dd 4-6 key responsibilities of the job Your skills and experience 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 skillsStrong critical reasoning, decision-making and problem solving skills to analyze situationsOrganizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectivesUnderstand Quality Systems and/or regulated training requirements Working Conditions (physical & mental requirements) Occasionally required to work with the public when they are dissatisfied80% of the time standing and walking and 20% of the time sittingReach, bend, kneel and have high level of manual dexteritySee and speak with customers and observe equipment operationOccasionally be required to lift and carry 25 lbs.Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors 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 #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!

Für unsere Abteilung Quality Assurance in Marburg suchen wir aktuell einen Dokumentationsmitarbeiter 1 BRM TG (m/w/d) - R-217842 (Vollzeit / befristet** / Tarif E7*) Ausschreibungsende 01.11.2023 Aufgaben Vorbereitung und Zusammenführung aller für die interne und behördenseitige Chargenfreigabe benötigten DokumentePrüfung der Dokumente auf Vollständigkeit und Plausibilität (z.B. Labor-, Produktions- und Endfertigungsprotokolle)Erstellen und Prüfen erforderlicher Reports auf Richtigkeit und Vollständigkeit (z.B. aus LIMS)Terminüberwachung und Beachtung der Fristen und Prioritäten der in Bearbeitung befindlichen ChargenVorbereitung und Organisation der Versendung von Prüfmustern für externe Stellen (z.B. Zulassungsbehörden)Koordination der zur Freigabe von Zukaufwaren (z.B. Helixate, Biostate) notwendigen AktivitätenSAP-Buchungen von Prüflosen in 3PL-DistributionslagernKoordination und Optimierung der Arbeitsabläufe mit den anderen Abteilungen in Absprache mit dem VorgesetztenErfassung und Autorisierung von Prüfergebnissen externer Prüflabore (z.B. LIMS)Erstellung und Autorisierung der Dokumentation von plasmatischen Zwischenproduktenbei am Standort Bern produzierten Chargen für den EU-Raum: Koordination der zur Freigabe notwendigen Aktivitäten und Weiterleitung der Dokumente an alle europäischen Niederlassungen der CSL BehringWeitergabe von chargenspezifischen Dokumenten an sowie Kommunikation (deutsch/englisch) mit europäischen Niederlassungen der CSL Behring und Kunden, z.B. Krankenhäusern, ApothekenErfassen und Verifizieren von chargenbezogenen Daten aus LIMS bzw. SAPErstellung und Validierung von Analysenzertifikaten aus LIMSErstellung von Master-Analysenzertifikaten nach Vorgaben der Kunden und/oder BehördenErstellung und Validierung von komplexen Routine-Analysenzertifikaten (z.B. USA, CA, MX, Iran)Zusammenstellen von Daten auf Kundenanforderung aus dem AnforderungskatalogAktualisierung und Neuerstellung von Anforderungskatalogen nach Vorgabe von Kunden und BehördenBearbeitung von Anfragen für RA und KliFoErstellen von SOPsZusammenstellen von Daten für Inspektionen und Kundenaudits (z.B. Recherche von Freigabedaten)In LIMS (Produktprüfung)Erstellen und Pflege von Daten für andere Abteilungen (z.B. Chargenmerkmale in SAP/QM-Modul)Festlegung neuer Maßnahmen im SAP–Freigabemanagement-Tool (Z4)Überprüfen von Behördenrechnungen gemäß Kostenverordnung, z.B. PEI; bei Abweichungen Klärung mit der BehördeFachliche Mitarbeit in Projekten Qualifikationen i.d.R. abgeschlossene 3,5-jährige Ausbildung, z.B. zum PharmakantenKenntnisse DatenbankenEnglisch Level 11-3 Jahre Berufserfahrung Wenn Sie Fragen zu dieser Position haben wenden Sie sich bitte an Mirko Altenkämper oder Mareike Hammerstädt, Senior Talent Acquisition Partner. *Erfüllt der künftige Stelleninhaber (m/w/d) das Anforderungsprofil der Position nicht, so kann er abweichend von der Stellenausschreibung in einer anderen Tätigkeit mit reduziertem Aufgabengebiet beschäftigt und somit in eine niedrigere Entgeltgruppe eingruppiert werden. **Der Befristung liegt ein Sachgrund zu Grunde. Die Besetzung der Stelle kann daher nur im Rahmen des Abschlusses eines entsprechend befristeten Arbeitsvertrags erfolgen. Dies gilt auch für interne Bewerbungen, die derzeit über einen unbefristeten Arbeitsvertrag verfügen Marburg, 18.10.2023 CSL Behring GmbH - Human Resources 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!

The Opportunity 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 managementCollaborate with center management in the development and implementation of continuous improvement plansCollaborate 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 concernsResponsible for coordinating and managing training activities, policies and processes at the center level. You will report to the Assistant Manager Quality The Role Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications.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.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.Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements.Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards.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 usedCollaborates 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.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.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.Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center.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.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.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.Follow all Standard Operating Procedures (SOPs), company policies and procedures.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.Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable.Assist Plasma center staff in completing other special projects or assignments, as requested.Perform other job-related duties, as assigned.dd 4-6 key responsibilities of the job Your skills and experience 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 skillsStrong critical reasoning, decision-making and problem solving skills to analyze situationsOrganizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectivesUnderstand Quality Systems and/or regulated training requirements Working Conditions (physical & mental requirements) Occasionally required to work with the public when they are dissatisfied80% of the time standing and walking and 20% of the time sittingReach, bend, kneel and have high level of manual dexteritySee and speak with customers and observe equipment operationOccasionally be required to lift and carry 25 lbs.Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors 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!

CSL is undergoing extensive and positive change as we expand and grow. In addition to contributing to Australia's export economy, CSL has invested $AUD2 billion over the last 4 years into Australia and continues to invest in substantial new manufacturing facilities to support CSL's global strategy and provide the network with crucial supply of product sourced from our Melbourne facilities. As CSL evolves, a position is available for an Associate Director, Regional Project Controls Lead, APAC. You will manage the deployment of Project Controls (PC) related policies, programs, and practices for our significant capital and operational investment across the Asia Pacific region. You will be responsible for standardised project controls execution across all project phases through implementing standard tools and best practices. You will work within project execution methodologies supporting training and communication. Additionally, you will monitor program delivery against industry and CSL best practices utilising benchmarking and key performance indicators. Reporting to the Global Project Controls Lead, Senior Director, your responsibilities will include: Support globally important capital and operational projects across the Australian CSL business with significant financial investment; Develop guides and standards and provide guidance and toolsYou will manage a matrix regional team including PMO leads, cost engineers, schedulers, risk managers and change managers and works with the regional project delivery team in managing the overall project control efforts.Develop internal/external benchmarking data to ensure we are showing continuous improvement in our capital project performance and perform program and project assurance reviews and risk assessmentsImplement leading practice metrics to ensure outcomes are captured to demonstrate improvements to current state and to identify leading indicators where course correction is required and takes action to addressWork with scheduling staff to develop, manage, revise, and update integrated detailed project schedules, including all phases of project executionEnsure projects are tracking and analysing the project costs including budgets, commitments, actuals, accruals, and forecasts. Analysis includes earned value, cashflow and contingency analysis To be successful: Degree in Project Management, Engineering, or related field / equivalent experienceProject Controls experience on capital or operational projects is required; Experience on projects >$AUD50M is desirableExperience of one or more of the following: earned value analysis, forecasting, best practice planning and scheduling of projects, financial capital planning, cash flow analytics, break-even analysis, creating Indicators, and tracking methodologiesExperience with the Primavera (P6) suite of products for project scheduling and risk analysis is advantageousExperience in BI and visualisation softwareAbility to influence partners; strong written and verbal communication skills Apply now to join CSL in an influential role in our organisation! Please include your resume and cover letter in the one document. 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!

The Opportunity 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 managementCollaborate with center management in the development and implementation of continuous improvement plansCollaborate 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 concernsResponsible for coordinating and managing training activities, policies and processes at the center level. You will report to the Assistant Manager Quality The Role Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications.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.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.Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements.Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards.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 usedCollaborates 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.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.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.Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center.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.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.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.Follow all Standard Operating Procedures (SOPs), company policies and procedures.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.Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable.Assist Plasma center staff in completing other special projects or assignments, as requested.Perform other job-related duties, as assigned.dd 4-6 key responsibilities of the job Your skills and experience 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 skillsStrong critical reasoning, decision-making and problem solving skills to analyze situationsOrganizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectivesUnderstand Quality Systems and/or regulated training requirements Working Conditions (physical & mental requirements) Occasionally required to work with the public when they are dissatisfied80% of the time standing and walking and 20% of the time sittingReach, bend, kneel and have high level of manual dexteritySee and speak with customers and observe equipment operationOccasionally be required to lift and carry 25 lbs.Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors 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!

Provide strategic and business direction for the Change Control and Risk Management functions. Initiate actions designed to support and achieve site’s objectives. 为变更控制和风险管理职能提供战略和业务方向，并发起旨在支持和实现工厂目标的行动。 Manage all operational aspects of the Change Management System. Ensure that GxP changes are processed, evaluated and appropriately documented in a timely manner. 管理变更管理系统的所有操作方面。确保GxP变更得到及时的处理、评估和适当的文档化。 Manage the Change Assessment Team (CAT) Meeting for the evaluation of process related changes. 管理变更小组以评估过程相关的变更。 Manage significant and complex changes related to process, facilities, materials, software, systems, and services with a GxP impact to ensure that changes are appropriate and comply with registered conditions. 管理与工艺、设施、物料、软件、系统和cGxP服务相关的重大和复杂的变更，并对cGxP产生影响，以确保变更是适当的并符合注册条件。 Review the GxP changes to ensure that changes are properly assessed and categorized, change actions are properly identified and changes are clearly documented. 审核变更，以确保变更被合理地评估和分级，行动项被合理地制定，以及变更被清晰描述。 Monitor and track change controls. Release or reject change actions as per completion status. 监控和跟踪变更控制。根据完成情况放行或退回变更行动。 Manage the business continuity of change control process. 管理变更控制流程的业务连续性。 Review change effectiveness check, approve the closure of change. 审核变更有效性核查，批准变更关闭。 Collect and report change control and risk management data to support Quality Reviews (e.g., QMR). 整理和报告变更控制和风险管理数据，以支持质量回顾(如质量管理评审)。 Support Product Release group with the timely management of change controls that are associated with product lots for release. 支持产品放行团队及时管理与放行产品批次相关的变更控制。 Advise relevant Quality Delegates and Managers on the requirements of the quality management systems with respect to change controls. 就变更控制方面的质量管理体系要求，向相关质量代表和经理提供建议。 Liaise closely with all key stakeholders to ensure timelines for change execution are met. 与所有关键利益相关者紧密联系，确保变更执行的时间限得到满足。 Provide technical and quality operations advice that is compliant to the quality change management system. 提供符合质量变更管理体系的技术和质量操作建议。 Delivery of DigiTrack Change Management Training, as required. 根据需要提供DigiTrack变更管理培训。 Establish and maintain Change Control Management and Risk Assessment Management procedures, including electronic system operation procedure. 建立和维护变更控制和风险管理程序，包括在电子系统中的操作程序。 Participate and support in risk management efforts as required to support the CSL business on behalf of the Quality Compliance and QA System team. 代表合规和QA体系团队参与支持CSL业务的风险管理工作。 Implement and support a compliant risk register. 实施并支持符合要求的风险登记。 Assess, control, communicate and review risk management efforts in line with current industry guidelines. 根据当前的行业指导方针，评估、控制、沟通和评审风险管理工作。 Manage the archiving process of documents related to change control and risk management to ensure data integrity. 管理变更控制和风险管理相关文件的规定过程，以保证数据可靠性。 Assist QA Compliance Manager to provide appropriate training and development to team staff, improve collaboration within and between groups, in order to complete relevant work in a timely/efficient manner. 协助合规经理对组内员工进行适当的培训和发展，改善组内和部门之间的合作，以便及时/高效地完成相应工作。 Take other tasks and duties as assigned by Line manager or department lead. 完成领导交办的其他工作。 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 organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!

The OpportunityThis position is responsible for administering and managing a wide range of learning and development activities. In consultation with department leaders, this role with ensure learning and development initiatives are consistent and aligned with corporate goals, culture and business results. This position is located in Union, SC - You will report to Manager, Quality Assurance The RoleLearning management system administrator maintaining up to date, accurate and organized employee training records, both electronic and paper.You will collaborate with department management to develop and manage appropriate curricula and on the job training (OJTs).Support local training policies, programs, and schedules, based on knowledge of identified training needs, company production processes, business systems, or changes in products, procedures, or services.You will ensure that all employees throughout CSL are trained in accordance with established standards, regulatory standards.Prepare and maintain training-related policies and procedures to comply with regulatory and certification requirements. Prepare reports and analysis of employee training requirements and training records.Lead, participate, and contribute to meetings with employees, supervisors and managers, teams, and other departments.Develop training manuals, reference tools, testing and evaluation procedures, multimedia visual aids, and other educational materials.Train assigned instructors and supervisory personnel in effective techniques for training, such as on-the-job training (OJT), health and safety practices, employee and leadership development, and adaptations to changes in policies, procedures, and technologies. Education Bachelor's degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry), or equivalent. ExperienceMinimum of 3-5 years GMP experience in pharmaceutical/biotech production environment.Experience in an FDA regulated industry and EMA requirementsKnowledge of current Good Manufacturing Practices (cGMP) principlesProficiency in Learning Management Software, electronic quality and operational systemsAbility to facilitate learning by diverse audiences.Lead the training activities in cross-functional work environment#LI-Onsite 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!

The Opportunity 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 managementCollaborate with center management in the development and implementation of continuous improvement plansCollaborate 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 concernsResponsible for coordinating and managing training activities, policies and processes at the center level. You will report to the Assistant Manager Quality The Role Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications.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.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.Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements.Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards.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 usedCollaborates 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.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.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.Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center.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.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.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.Follow all Standard Operating Procedures (SOPs), company policies and procedures.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.Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable.Assist Plasma center staff in completing other special projects or assignments, as requested.Perform other job-related duties, as assigned.dd 4-6 key responsibilities of the job Your skills and experience 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 skillsStrong critical reasoning, decision-making and problem solving skills to analyze situationsOrganizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectivesUnderstand Quality Systems and/or regulated training requirements Working Conditions (physical & mental requirements) Occasionally required to work with the public when they are dissatisfied80% of the time standing and walking and 20% of the time sittingReach, bend, kneel and have high level of manual dexteritySee and speak with customers and observe equipment operationOccasionally be required to lift and carry 25 lbs.Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors 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!

Business Analyst, QC Excellence Instrumentation (m/f/d) In the role as Business Analyst, QC Excellence Instrumentation (m/f/d) you will support laboratory instrumentation and automation infrastructure in the operational QC testing environment. You will carry out automation solution validations for our site in Bern, Switzerland and collaborate with our sites in Europe, Australia and the United States for global qualification and validation projects. Your responsibilities include, but are not limited to: Support laboratory instrumentation and automation infrastructure in an operational testing environmentEnsure laboratory automation applications are validated and maintained according to company policies and procedures and in compliance with GxP requirementsCreate documentation in English and German for qualification, validation and lifecycle management of existing and newly implemented laboratory automation systems and software applications in collaboration with Engineering and I&T departmentsManage local and global qualification and validation projectsCollaborate with internal and external stakeholders within qualification and validation projects for technical requirement specifications, data integrity and automation activitiesSupport update of procedures related to laboratory automation and computerized systems (i.e. USP, 21CFR Part 11, Annex 11 regulations) to ensure compliance with guidelines and industry best practice, as well as harmonization within the global organizationSecond level user support for operational QC labs on instrumentation providing technical support, coordinating complex troubleshooting activities with QC external providers (i.e. Laboratory Execution Systems, I&T, external service providers) Who you are: In this role you will collaborate with relevant stakeholders to ensure laboratory equipment and automation systems are operating in a qualified environment. With your proactive and self-responsible approach, you take decisions and drive progress forward. The below competencies will help you to be successful in this role: University degree in a relevant discipline (Computer Science, Software Engineering, etc.)3+ years' experience in a pharmaceutical/medicinal GMP testing environment within CSV Project management experience in an operational environmentKnowledge of regulations on computerized systems and laboratory automation and willingness to extend skills and know-how on the fieldExperience with basic programming Language (e.g. Java Script)Strong written & verbal communication in German and English, both oral and written to ensure effective collaboration with cross-functional teams both locally and globally Strong analytical/problem solving and organizational skillsAble to work independently and as a team member in a high performance environment We are looking forward to receiving your online application. Applications must include a motivation letter and CV, as well as letters of references and copies of relevant transcripts and/or diplomas in the original language. Please include all these in one document together with the CV. CSL Behring is committed to provide equal employment opportunity for all. 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!

The Opportunity 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 managementCollaborate with center management in the development and implementation of continuous improvement plansCollaborate 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 concernsResponsible for coordinating and managing training activities, policies and processes at the center level. You will report to the Assistant Manager Quality The Role Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications.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.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.Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements.Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards.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 usedCollaborates 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.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.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.Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center.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.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.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.Follow all Standard Operating Procedures (SOPs), company policies and procedures.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.Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable.Assist Plasma center staff in completing other special projects or assignments, as requested.Perform other job-related duties, as assigned.dd 4-6 key responsibilities of the job Your skills and experience 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 skillsStrong critical reasoning, decision-making and problem solving skills to analyze situationsOrganizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectivesUnderstand Quality Systems and/or regulated training requirements Working Conditions (physical & mental requirements) Occasionally required to work with the public when they are dissatisfied80% of the time standing and walking and 20% of the time sittingReach, bend, kneel and have high level of manual dexteritySee and speak with customers and observe equipment operationOccasionally be required to lift and carry 25 lbs.Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors 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!

The Opportunity 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 managementCollaborate with center management in the development and implementation of continuous improvement plansCollaborate 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 concernsResponsible for coordinating and managing training activities, policies and processes at the center level. You will report to the Assistant Manager Quality The Role Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications.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.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.Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements.Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards.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 usedCollaborates 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.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.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.Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center.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.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.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.Follow all Standard Operating Procedures (SOPs), company policies and procedures.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.Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable.Assist Plasma center staff in completing other special projects or assignments, as requested.Perform other job-related duties, as assigned.dd 4-6 key responsibilities of the job Your skills and experience 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 skillsStrong critical reasoning, decision-making and problem solving skills to analyze situationsOrganizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectivesUnderstand Quality Systems and/or regulated training requirements Working Conditions (physical & mental requirements) Occasionally required to work with the public when they are dissatisfied80% of the time standing and walking and 20% of the time sittingReach, bend, kneel and have high level of manual dexteritySee and speak with customers and observe equipment operationOccasionally be required to lift and carry 25 lbs.Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors 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!

Reports To: Group LeadPosition Overview: The incumbent is responsible for ensuring inter- and cross-shift communication pertaining to manufacturing issues, instrument troubleshooting, test scheduling, testing delays, and real time reporting EHS incidents. Additionally, you will coordinate/perform analyst training and ensures proper documentation, mentors analysts, recognizes and reacts to problems associated with laboratory procedures, performs and reviews investigations of out-of-limit results, keeps the work environment safe, and ensures shifts adhere to safety procedures/policies. Key Responsibilities:Responsible for supervising daily activities of laboratory group to ensure compliance with quality and reliability standardsSupervises the use of chemical tests and various kinds of measuring instruments in accordance with approved methods and standard operating procedures (SOPs)Schedules and communicates with appropriate functional groups regarding status of activities and quality testing requirementsProvides expert review of data, protocols and reports for adherence to cGMPs and good documentation practicesCommunicates aberrant results and leads investigation to determine root causeEnsures quality control training and reviews and approves standard operating procedures (SOPs) Education:Bachelor’s degree in a relevant scientific discipline (Chemistry, Biology, Biochemistry, etc.) Experience:3-5 years' quality control experience in the pharmaceutical/biotech/or other regulated industry QualificationsLeadership/ team management skillsDirect interaction with regulatory agenciesKnowledge of current Good Manufacturing Practices (cGMP) principlesKnowledge of FDA and EMA requirements Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable. Our BenefitsCSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what’s available to you as a CSL employee. 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 organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!

CSL is a leading global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat hemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency, dialysis and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our three businesses, CSL Behring, CSL Seqirus and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. CSL’s Co-op Program is a hands-on experience that showcases the daily innovation and operations of a leading biotechnology company. Our environment is collaborative, global, and purpose-driven. The 26-week experience will immerse students in meaningful, thought-provoking projects that contribute to CSL's promise to save lives and protect the health of people around the world. In addition to making an impact, students will be developed personally and professionally while cultivating meaningful relationships. Main Responsibilities Reporting to the head of digital & brand and taking work direction from members of the global digital & brand center of excellence team, the person in this role will provide support to the team and associated stakeholders in the running of day to day digital operations encompassing the use of the company's portfolio of tools and channels used for internal and external communication. •Support the global Corporate Communications team to “Deliver on their Promises” by contributing to the success of communications campaigns and activities. •Liaise with stakeholders to support current initiatives. •Help manage digital tools and content processes that enable internal and external communications such as employee mobile news apps, social media management tools, and publishing tools for internal and external websites: •Produce graphics, motion graphics, and video to drive engagement, particularly on social media channels. •Use analytics to adapt and improve. •Learn and apply CSL’s brand standards in the creation of digital assets. Qualifications •Enrolled in a 4-year university with progression toward an undergraduate degree in Digital Graphics related field •Working knowledge and experience essential of working with advanced digital content tools in the context of marketing and communications •Excellent communication and presentation skills •Ability to work well with all levels of the organization •Demonstrates flexibility and acceptance of assignments and schedules •Enthusiasm to learn new tools & technologies •Maintains professional behavior Our BenefitsCSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what’s available to you as a CSL employee. 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 organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!

Senior Employee Relations Manager GENERAL SUMMARY The Senior Employee Relations Manager for the Global Employee Relations Group is responsible for managing employee relations issues for their region. This includes ownership and management of each ER case from intake to remediation and follow-up as necessary. ER cases include investigating and resolving cases that are difficult and complex complaints and conflicts in the workplace that require analysis of issues and consideration of other areas while balancing a broad set of issues, procedures and policies. This role serves as an advisor to CSL managers and senior management regarding policies and procedures related to the management of their team. Senior Employee Relations Manager will work with the ER team, HR Business Partners, Managers, employees, Legal and other departments to administer and manage ER services. The Senior Employee Relations Manager seeks to improve the employee experience while assessing, advising and decreasing the risk to the company. REPORTING RELATIONSHIP Reports To: Regional ER Lead or Director RESPONSIBILITIES EMPLOYEE/INDUSTRIAL RELATIONS Manage complex ER cases to resolution independently and in collaboration as necessary with peers, ER management, respective HR Business partners, legal counsel, and other stakeholders. Complex ER cases include factors such as visibility on the case, a high number of staff involved, higher risk to the organization, and high-level staff involved, including the potential involvement of external investigative agencies or regulators. Senior Employee Relations Managers are able to identify the risk factors in ER cases and propose and/or direct the strategy and resolution of the case.Conducts confidential investigations into serious misconduct, such as harassment, discrimination, or other breeches of company policy. Gathers information, interviews relevant individuals, analyzes data, and prepares legally sound documentation to support all disciplinary and/or termination actions. Recommends a course of action based on the facts, CSL Values and then coach management through the implementation of each action. Minimizes risk and exposure for CSL by maintaining fair, legally sound, fully documented, and unbiased approach when conducting investigations and implementing actionsReceive and investigate Compliance Hotline/Speak Up cases through resolution and complete all process documentation in appropriate systemFacilitate terminations including termination letters, termination meeting, and related documentationEvaluate and analyze situations or data that require knowledge of company process, policies, and business needsProvide feedback and guidance to business management regarding employee relations best practices and ensure fair treatment of employees while mitigating risk Influence and gain buy-in from managers in sensitive situations, while building the relationshipParticipate in program development and facilitate training on ER services with the Learning department, i.e., accommodations, policy violationsPartner with internal and external employment law counsel as appropriate, including appropriately identify and coordinate cases with legal counsel as necessary, modifying case responses and/or ensuring stakeholders are advised of recommendations to achieve business objectives while minimizing riskWorks collaboratively to ensure consistent application and interpretation of company policies and contracts In Unionized / Works Council environments, facilitates resolution of labor grievances, disputes, employee issues and concerns. Conducts investigations and coordinates arbitrations as appropriate. Interprets union-management collective bargaining agreements and represents management in the negotiation and settlement of grievances under established grievance procedures. Work may be directed by an Industrial Relations or Works Council Manager at certain locations Interacts with employees, the designated union representatives and/or Works Council to build a positive rapport and foster a collegial and collaborative working environmentAssists in the development and updates of regional materials and tools to provide support to the HR Operations Centers and managers on Employee Relation issues and policiesMEDICAL ACCOMMODATIONS Manage medical accommodation process in conjunction with other CSL and external stakeholdersFacilitate interactive discussions with relevant HR Business Partners and medical expertsAdvocate for the employee and work toward balancing our CSL Values to find solutionsAbility to recommend and implement creative solutions with the HRBP and business groupsDocument and record determination of approved or denied medical accommodation in appropriate systemCORRECTIVE ACTION Educate business leaders on corrective action and potentially the annual review processes including SMART objectives. Emphasize to leaders the importance of early intervention and provide ongoing coaching and feedbackAdvise management on appropriate resolution of employee behavior and performance issues. Supports managers in the development and review of corrective action, including performance improvement plansConsults with managers on driving a culture of high performance and engagement at CSL Document and record employee actions in appropriate systemSPECIAL PROJECTS/ADMINISTRATION Completes special HR/ER related projects by clarifying project objective, setting timetables and schedules, conducting research, developing and organizing information and delivering against project objectivesPerforms other duties as assigned or as may be necessaryRecord and correctly maintain all case management requirements in systems for reporting and complianceJOB SPECIFICATIONS EDUCATION Bachelor’s Degree in Human Resource management, organizational psychology, business, or closely related field is essentialProfessional HR certification preferredEXPERIENCE Minimum of 5 - 7 years’ experience as a HR Generalist, HRBP, Employee Relations Manager (or equivalent relevant experience working in a dynamic global organization)Demonstrated experience managing investigations and employee relationsStrong knowledge of HR processes gained in a dynamic organizationExperience in a global company in a matrixed reporting environment is preferredExperience supporting multiple locations remotely strongly preferredLabor or works council experience strongly preferredADDITIONAL COMMENTS Strong knowledge of employment related laws at the county/regional level. Maintains knowledge of legal requirements and government reporting regulations impacting HR functions and ensure compliant, consistent application of policies and proceduresStay current on changes in employment regulation and recommends improvements to ER LeadStrong communication skills, written, verbal and in presentationAbility to manage and balance complex employee relations cases and investigationsHigh employee, customer, and colleague focusOrganizational skills, ability to set priorities for self and others, and meet deadlinesResults-oriented and sense of urgencyDiplomacy and ability to handle confidential information with discretionAbility to build strong relationships and positively influence othersExpert conflict facilitation and resolution skillsMultiple language skills preferred WORKING CONDITIONS Ability to make decisions which have high impact on the department’s credibility, operations, and servicesAbility to compose materials such as detailed reports, management and executive summaries, work-related manuals, publications to limited scope or impact, etc. and/or to make presentations outside the immediate work areaOvernight travel required up to 20% of the timeFast paced environment with frequent interruptions 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!

Purpose: Global lead counsel responsible for establishing and leading the Regulatory, Safety and Pharmacovigilance legal center of excellence (COE), including providing and coordinating specialist legal advice on regulatory, safety and pharmacovigilance matters in CSL’s key jurisdictions, on an enterprise wide basis. Responsibilities: Provide Specialist Legal Advice to CSL’s Global Regulatory Affairs (GRA) and Global Clinical Safety & Pharmacovigilance (GCSP) organizations on a broad range of legal and regulatory issues related to the Group s R&D pipeline, on-market products and lifecycle management initiatives, including product registration and regulatory strategy, labeling, data exclusivity, regulatory supply chain issues, reporting, import and export requirements, GxP matters, clinical safety, pharmacovigilance, product recalls, expanded access, orphan drug designation, fast track designation, breakthrough designation, early access or special access programs, accelerated approval and priority review. Advise on compliance with any regulatory post-market requirements. Serve as trusted legal partner on the Global Regulatory and Clinical Safety leadership teams, andto the EU QPPV. Represent Legal on the Global Benefit Risk Committee Provide legal support and strategic advice to CSL’s interactions with international regulatory agencies and health authorities, including the development of legal arguments for inclusion in regulatory submissions and assisting with preparations for formal meetings with agencies and advisory committee meetings. Support the regulatory and safety aspects of CSL’s licensing and M&A transactions, including by supporting regulatory and safety due diligence, negotiating key regulatory and safety terms andm supporting any post-transaction integration and other activities. Act as a key liaison between the deal team and CSL’s internal client group to ensure CSL’s functional and operational requirements with respect to safety and regulatory matters are accounted for in all transaction. Provide litigation support, in conjunction with General Counsel, Global R&D and Strategy and outside counsel, for regulatory and safety matters. Pro-actively develop and maintain a broad and deep knowledge of applicable laws and regulations, industry practices and standards, as well as key developments in the global regulatory environment relevant to CSL’s business Participate and represent CSL in external industry forums and networks as appropriate. Develop and deliver training to the business on regulatory, safety and pharmacovigilance legal matters as required or requested. Develop a suite of template clauses and agreements necessary to support key pharmacovigilance and safety matters. Qualifications:Bachelor’s degree and J.D. or equivalent foreign degree Bar admission in relevant region or permission to practice in-house Minimum of 12 years' experience providing legal advice on regulatory, safety and pharmacovigilance issues to pharmaceutical or biotechnology companies, either in-house or at a law firm with a reputable regulatory life sciences practice Our BenefitsCSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what’s available to you as a CSL employee. 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 organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!

The Opportunity:Reporting to the Lead Counsel, Commercial, North America, as the Senior Counsel, North America Commercial Operations, you will be responsible to provide informed, actionable legal support and strategic counsel for North America Commercial Operations of CSL Behring. This is a hybrid role, which requires some onsite work. #LI-hybrid The Role:Interact directly with members of North America commercial leadership team and all levels of commercial management, and advise business leaders on a broad range of legal issues related to the commercial activities of a $5 billion North American specialty pharmaceutical business.Directs contract strategy with regard to a wide range of strategic commercial contracts, including value based arrangements, product purchase and rebate agreements, tender and toll agreements, distribution services agreements, investigator initiated studies, education and research grants and material transfer agreements.Responsible for providing strategic and tactical counsel on priority business initiatives to help ensure achievement of annual sales targets.Serve as lead brand lawyer for the products in one or more therapeutic areas, including by participating as legal representative/reviewer on Promotional Review Committee and by collaborating closely with clients to help them navigate competitive legal risks in the US market.Collaborate with global intellectual property attorneys on IP matters.Manages litigation and negotiates and resolution of commercial disputes; manages activities related to company investigations.Partnering with legal peers in other regions, provide legal advice and support in connection with non-routine special projects, such as business development activities and other strategic business transactions involving CSL Group companies.In collaboration with Compliance, ensure business processes and activities are and remain in compliance with applicable laws, regulations, and company policies, and to maintain open and effective avenues of communication among Legal, Compliance, and the business.Coordinate work with outside counsel, and coordinate legal advice on a global basis as required.Establish and build good working relationships with internal clients based on mutual trust and respect and knowledge of the company’s business and its needs and goals. Your Skills and Experience:Bachelor’s degree and Juris Doctor. Superior academic credentials at top-tier law school strongly preferred.Must be licensed to practice law in Pennsylvania (preferred), or hold (or be eligible for and able to obtain promptly) a Limited In-House Corporate Counsel License under PA BLE Rule 302.Minimum of 10 years applicable Legal and/or Compliance experience required, including 8 supporting a pharmaceutical or device company, either as in-house or external counsel. Demonstrated familiarity with the Anti-kickback statute; False Claims Act; Food, Drug, and Cosmetic Act and supporting regulations; PhRMA Code; and state and federal privacy laws. Experience in some or all of the following areas: promotional review, commercial contracting, government pricing and/or price reporting, Sunshine Act transparency reporting, pharmaceutical or device compliance, government/internal investigations, and/or commercial and product-liability litigation.Experience at top-tier law firm preferred. Judicial clerkship considered a plus. Strong drafting and negotiation skills required, as well as ability to produce quality work under pressure and while balancing multiple priorities.Strong communication, analytical, project management, interpersonal skills; ability to understand business needs and goals and incorporate that understanding in advice to the business that enables the business to make well-informed decisions based on a full understanding of risks and benefits. Working Conditions: Hybrid work environment. Minimum of 25% of time in the King of Prussia office is expected. Our BenefitsCSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what’s available to you as a CSL employee. 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 organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!

Job Description SummaryResponsible for minor maintenance repairs and the clean and orderly appearance of the collection center. Job Description ​ 1 Cleans table, chairs, cabinets, counters and appliances located in the employee break room and donor waiting area. 2 Vacuums carpets, dusts furniture and removes trash. 3 Cleans windows and doors at least daily. 4 Performs minor maintenance tasks such as changing light bulbs, replacing ceiling tiles, painting, minor plumbing and carpentry tasks. 5 Monitors the grounds and parking lots around the center and picks up litter as required in these areas. 6 Assists in recycling and repackaging of shipping materials. 7 Inspects and cleans restrooms throughout the day. Replaces paper and soap supplies. Performs minor custodial tasks in area as required. 8 Physically receives supplies from vendors and moves supplies from storage area to released and quarantined areas. 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 job-related duties as assigned. Education • High school diploma or equivalent required Experience • Minimum three (3) months experience as a custodian preferred or equivalent combination of education and experience • 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 40 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. 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 SummaryResponsible for minor maintenance repairs and the clean and orderly appearance of the collection center. Job Description ​ 1 Cleans table, chairs, cabinets, counters and appliances located in the employee break room and donor waiting area. 2 Vacuums carpets, dusts furniture and removes trash. 3 Cleans windows and doors at least daily. 4 Performs minor maintenance tasks such as changing light bulbs, replacing ceiling tiles, painting, minor plumbing and carpentry tasks. 5 Monitors the grounds and parking lots around the center and picks up litter as required in these areas. 6 Assists in recycling and repackaging of shipping materials. 7 Inspects and cleans restrooms throughout the day. Replaces paper and soap supplies. Performs minor custodial tasks in area as required. 8 Physically receives supplies from vendors and moves supplies from storage area to released and quarantined areas. 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 job-related duties as assigned. Education • High school diploma or equivalent required Experience • Minimum three (3) months experience as a custodian preferred or equivalent combination of education and experience • 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 40 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. 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 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 minor maintenance repairs and the clean and orderly appearance of the collection center. Job Description ​ 1 Cleans table, chairs, cabinets, counters and appliances located in the employee break room and donor waiting area. 2 Vacuums carpets, dusts furniture and removes trash. 3 Cleans windows and doors at least daily. 4 Performs minor maintenance tasks such as changing light bulbs, replacing ceiling tiles, painting, minor plumbing and carpentry tasks. 5 Monitors the grounds and parking lots around the center and picks up litter as required in these areas. 6 Assists in recycling and repackaging of shipping materials. 7 Inspects and cleans restrooms throughout the day. Replaces paper and soap supplies. Performs minor custodial tasks in area as required. 8 Physically receives supplies from vendors and moves supplies from storage area to released and quarantined areas. 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 job-related duties as assigned. Education • High school diploma or equivalent required Experience • Minimum three (3) months experience as a custodian preferred or equivalent combination of education and experience • 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 40 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 Description SummaryResponsible for minor maintenance repairs and the clean and orderly appearance of the collection center. Job Description ​ 1 Cleans table, chairs, cabinets, counters and appliances located in the employee break room and donor waiting area. 2 Vacuums carpets, dusts furniture and removes trash. 3 Cleans windows and doors at least daily. 4 Performs minor maintenance tasks such as changing light bulbs, replacing ceiling tiles, painting, minor plumbing and carpentry tasks. 5 Monitors the grounds and parking lots around the center and picks up litter as required in these areas. 6 Assists in recycling and repackaging of shipping materials. 7 Inspects and cleans restrooms throughout the day. Replaces paper and soap supplies. Performs minor custodial tasks in area as required. 8 Physically receives supplies from vendors and moves supplies from storage area to released and quarantined areas. 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 job-related duties as assigned. Education • High school diploma or equivalent required Experience • Minimum three (3) months experience as a custodian preferred or equivalent combination of education and experience • 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 40 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 Description SummaryResponsible for minor maintenance repairs and the clean and orderly appearance of the collection center. Job Description ​ 1 Cleans table, chairs, cabinets, counters and appliances located in the employee break room and donor waiting area. 2 Vacuums carpets, dusts furniture and removes trash. 3 Cleans windows and doors at least daily. 4 Performs minor maintenance tasks such as changing light bulbs, replacing ceiling tiles, painting, minor plumbing and carpentry tasks. 5 Monitors the grounds and parking lots around the center and picks up litter as required in these areas. 6 Assists in recycling and repackaging of shipping materials. 7 Inspects and cleans restrooms throughout the day. Replaces paper and soap supplies. Performs minor custodial tasks in area as required. 8 Physically receives supplies from vendors and moves supplies from storage area to released and quarantined areas. 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 job-related duties as assigned. Education • High school diploma or equivalent required Experience • Minimum three (3) months experience as a custodian preferred or equivalent combination of education and experience • 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 40 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 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!