CSL

Für unsere Abteilung Quality Assurance suchen wir in unserem Plasmacenter in Frankfurt einen Sachbearbeiter Qualitätsmanagement (m/w/d) - R-202297 (Vollzeit / befristet) Sie sind für folgende Aufgaben verantwortlich: Betreuung, Implementierung und Überprüfung von Maßnahmen zur Qualitätssicherung unter Anwendung der etablierten Q-Systeme. Sie stellen Quality Oversight im Plasmacenter sicher. Bearbeitung und Koordinierung von Abweichungen, Änderungsanträgen, Dokumenten-Revisionen, sowie Erstellung und Genehmigung von GMP-Dokumenten und Bearbeiten von Reklamationen Eigenständige Betreuung als QM-Beauftragter im Plasmacenter. Sie fungieren als zentraler Ansprechpartner in allen Qualitätssicherungsbelangen. Mitwirkung bei der Weiterentwicklung des konzernweiten Qualitätsmanagements Planung und Durchführung von Schulungen Vorbereitung, Durchführung und Nachverfolgung von internen und externen Audits, GEMBA Walks Leiten von Projekten im Verantwortungsbereich Sie sind qualifiziert durch: Erfahrung als Qualitätsmanagementbeauftragte/r und/oder Erfahrung im GMP-Umfeld Hohes Maß an Begeisterungsfähigkeit, Eigeninitiative und selbständige Arbeitsweise Sehr gutes Qualitätsbewusstsein und analytisches sowie lösungsorientiertes Denken & Handeln Gute Englischkenntnisse in Wort und Schrift Fortgeschrittene EDV-Kenntnisse in den Office Anwendungen Bereitschaft zu Reisen im Umfang von ca. 5-10% der Arbeitsze Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSL PlasmaCSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma. We want CSL to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Plasma!

Für unsere Abteilung Quality Assurance suchen wir in unserem Plasmacenter in Göttingen einen Sachbearbeiter Qualitätsmanagement (m/w/d) - R-212209 (Vollzeit / befristet für 1 Jahr im Rahmen einer Elternzeitvertretung) Sie sind für folgende Aufgaben verantwortlich: Betreuung, Implementierung und Überprüfung von Maßnahmen zur Qualitätssicherung unter Anwendung der etablierten Q-Systeme. Sie stellen Quality Oversight im Plasmacenter sicher. Bearbeitung und Koordinierung von Abweichungen, Änderungsanträgen, Dokumenten-Revisionen, sowie Erstellung und Genehmigung von GMP-Dokumenten und Bearbeiten von Reklamationen Eigenständige Betreuung als QM-Beauftragter im Plasmacenter. Sie fungieren als zentraler Ansprechpartner in allen Qualitätssicherungsbelangen. Mitwirkung bei der Weiterentwicklung des konzernweiten Qualitätsmanagements Planung und Durchführung von Schulungen Vorbereitung, Durchführung und Nachverfolgung von internen und externen Audits, GEMBA Walks Leiten von Projekten im Verantwortungsbereich Sie sind qualifiziert durch: Erfahrung als Qualitätsmanagementbeauftragte/r und/oder Erfahrung im GMP-Umfeld Hohes Maß an Begeisterungsfähigkeit, Eigeninitiative und selbständige Arbeitsweise Sehr gutes Qualitätsbewusstsein und analytisches sowie lösungsorientiertes Denken & Handeln Gute Englischkenntnisse in Wort und Schrift Fortgeschrittene EDV-Kenntnisse in den Office Anwendungen Bereitschaft zu Reisen im Umfang von ca. 5-10% der Arbeitsze Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSL PlasmaCSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma. We want CSL to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Plasma!

As a successful C&Q Engineer you ensure that Commissioning and Qualification are performed according to global and local company policies and standards as well as legal requirements and requirements set by regulatory authorities. You are responsible for planning, developing and executing commissioning and qualification for CAPEX- and OPEX-projects at CSL Behring. In detail, your responsibilities include: Planning, coordination and execution of all phases for commissioning and qualification of GMP manufacturing systems according to local and global procedures and standards as well as legal requirements.Facilitating the development, performing review and approving technical and GMP related documentation (URS, impact/risk assessment, Master plans, qualification/validation documentation)Development of C&Q verification documents including but not limited to Commissioning/ Qualification plans, FMEA, IQ, OQ as well as for the execution of verification activitiesCoordination and oversight of vendor FAT/SAT, commissioning activities in collaboration with internal and external partnersPlanning and execution of PQ’s including sterilization / depyrogenisation cycle development, Smoke Study, Temperature/Humidity mappingAssessing and handling of Change Controls, CAPAs and Non-Conformances related to qualification topicsWork collaboratively with all stakeholders, Process Engineering, Project Delivery, Execution Systems, PALM Validation, PALM Stability, Value Streams, R&D, QC staff and others, to ensure that activities are planned and delivered in an efficient timeframeProvide support and management to the multi-site projects to deliver on the company key CapEx projects Who you are: Master degree in a relevant science or engineering disciplineProven work experience in biotech or pharma company in an cGxP environment and/or C&Q equivalent positionExperience and knowledge in sterilization / dehydrogenization is a plusKnow-how of Commissioning and Qualification requirements according to cGMP regulations and international guidelinesExcellent written German and EnglishAbility to communicate clearly and effectivelyAnalytical thinking and problem-solving abilitySelf-time managementExcellent team player 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!

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 OpportunityThe Assistant Manager Quality (AMQ) reports to the Associate Director Quality. This position is located on site at our center in Duluth MN. The Role Ensure the center is "inspection ready" by managing adherence to Standard Operating Procedures (SOPs), compliance policies and the quality system.Manage the Quality Control program, calibrations management, monitor of compliance to defined processes e.g. sampling, competency checks, trending and analysis of KPIs, cause and failure mode impact assessment and change management.You will recruit, hire, conduct performance reviews, lead investigations and deviations, enact corrective actions, and termination.Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA), federal, state and local regulatory, company policies and procedures.Follow all HR policies and practices through fair treatment of all employees.Monitor CAPA's and effectiveness checks to ensure issues are resolved.Overnight travel required up to 10% of the time.Your skills and experience Education Bachelor's Degree preferred OR equivalent combination of education and professional work experience required Experience 1 year supervisory, leadership experience responsible for overseeing the activities of others OR Completion of CSL Plasma Leadership Development program1year Quality experience (CSA/CSAb) required Working Conditions Exposure to hazardous chemicals, extreme temperatures and to bloodborne pathogens.Required to wear Personal Protective Equipment while performing tasks or in certain areas 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 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!

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!

Responsibilities: • Tests various components of the quality control program in accordance with company standards and GMP regulatory guidelines • Performs tests in accordance with established methods and properly documents test results. Maintains a high level of expertise in area's testing methods • Evaluates performance of analytical instruments and equipment and recommends new acquisition or replacements. Assists in instrument qualification process • Evaluates, modifies and implements analytical methodologies developed and ensures smooth transfer of methodologies to routine use • Authors protocols and reports for suitability studies, investigations and other studies as required to support testing and compliance issues • Ensures laboratory instruments are qualified, calibrated and properly maintained and documentation complies with cGMP standards • Assists in development of new methods and procedures and maintains standard operating procedures (SOPs) • Documents quality issues and performance measures for management review • Works independently on projects • Represents laboratory on company cross-functional team Qualifications: • Bachelor degree in a relevant scientific discipline (Biology, Microbiology, Chemistry, etc.) • 5+ years' lab experience • Knowledge of cGMP standards and compendial methods • Strong analytical, quantitative, and problem-solving skills • Proficiency in microbiological testing methods (bioburden, sterility, growth promotion, microbial identification, endotoxin, etc.) • Capacity to work independently and ability to prioritize tasks and meet deadlines • Ability to manage, analyze and trend large data sets • Proficiency in Microsoft Office and QC Systems • Knowledge of Alternative Rapid Microbiology methods and automation is a plus • Use of molecular methods for microbiological testing and product characterization is a plus 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!

The Opportunity RELOCATION and TRAVEL REQUIRED CSL Plasma is one of the World's largest collectors of human plasma. Our work helps ensure that tens of thousands of people with rare and serious diseases live normal, healthy lives. CSL Plasma has 300+ collection centers in the U.S. Our Management Trainees are partnered with some of our most experienced, knowledgeable and passionate leaders across the fleet. The Role ​This is a 6 – 9 month accelerated training program, and offers professionals a Promising FUTURE with a clear career path. You can expect to receive development opportunities through live environment and classroom-style training, one-on-one mentoring, networking and travel opportunities. You will relocate with a promotion to Assistant Manager Quality at any one of CSL's plasma centers located within the states of Texas, New Mexico or Oklahoma after training is completed. Company paid relocation assistance provided. overnight travel up to 25% of time. You will report to the Assistant Manager Quality. Three Phases of the Management Trainee Program: 1. Production Training (6 weeks): You will learn staff responsibilities, including: Medical Reception Technician, Donor Support Technician, Phlebotomy and Plasma Processing Technician. 2. Center Leadership Training (10 – 14 weeks): You will travel overnight a total of 5 weeks to our leadership training sites (1 – 3 weeks at a time) to attend classroom style and live-environment training. 3. Leadership Experience & Development (12 weeks): You will receive weekly one-on-one mentoring with your Sponsor (mentor) and complete a series of leadership development classes. Some of your daily responsibilities will include: Trending and investigations of deviationsChange management and improvement plansProvide feedback to staff on observationsLead audits and ensure center is inspection-ready.After completing the three phases, you will be eligible to apply for a promotion. You will travel overnight to support other centers until promoted. Your Skills and Experience Education: Bachelor's degree or equivalent combination of education and professional work experience including 1 year supervisory or leadership experience. Your Benefits: Medical/Dental/Vision - (eligible on day one of employment)Maternity/Paternity LeaveShort and Long-term disabilityTuition assistance401(k) plan15 days of PTO4 personal holidays9 company holidays annuallyCSL Share Plan (15% Discount)Well-Being ProgramFinancial Advising & Legal ServicesAdoption Assistance 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!

We are looking for a QC Analytical Technology Project Manager The QCAT Project Manager is responsible for oversight and management of global QCAT Projects. The QCAT Project Manager will work with the Product Analytical Owner(s), Head(s) of QCAT and QC leadership to develop and execute project plans to meet the strategic objectives of global QC. The QCAT Project Manager will establish and facilitate project teams, provide communication and escalation of project status and challenges to stakeholders and sponsors and will develop and track multi-functional, integrated project plans that include resourcing and material requirements to deliver against project milestones and will facilitate negotiation with stakeholders and resource managers to secure allocation and coordination of resources to drive project completion. Education BS/BA in Engineering, Physical, or Biological Science or other appropriate technical field. Masters or Doctoral degree preferred. Experience At least 1 years’ experience in managing projects with at least 3 years’ experience in method development for assessment of biological pharmaceutical products or equivalent Experienced and knowledgeable in project management and leadershipProven skills in problem solving, analytical/conceptual thinking and time management.Is knowledgeable about Analytical Method Lifecycle management, cGMP QC release and pharmaceutical regulatory management.Has worked in project teams and ideally has experience in leading multi-functional project teams.Experience in change management processes and toolsExperience in strategic planning and executionHighly developed interpersonal and communication skills, including presentation of data/status to senior managementPossesses knowledge and experience of quality systems and quality risk management Competencies Effective and risk-based decision-making capacityStrong and effective communication skillsMatrix management skillsCustomer FocusStrong organizational skillsResourcefulnessPragmatic and innovative approach to problem solving 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!

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!

This position is responsible for the support of a broad range of Environmental, Health and Safety programs. The position offers an opportunity to progress skills in a variety of EHS disciplines. The primary responsibility of the EHS Specialist is identifying, defining, and managing the EHS requirements (internal & external) for the site and the Value Steam (Departments) and serving as the subject matter expert for these requirements. The RoleManage site EHS programs to ensure on-going compliance through reviews, corrective action, and continuous improvement. Safety programs include: Fall Protection, Hazard Communication, Powered Industrial Trucks, Electrical Safety, Lockout/Tagout, PSM/RMP, Hot Work, Biological Safety, Chemical Handling & Hygiene, Fall Protection, Environmental Compliance, Permit Management, PPE, Waste Management, and Work Permits. Lead risk identification and analysis exercises focusing on manufacturing, laboratory, and maintenance activities (includes Job Hazard and PPE assessments). Conduct EHS assessments for chemical, biological, physical hazards in the workplace and keep appropriate records and write reports of findings. Working with operational staff and EHS senior staff to document program challenges and help develop corrective actions and appropriate follow up. Participate in the EHS incident management program: Reviews and categorize incident reports, investigations, and CAPA; Participates in and assist with incident investigations; Tracks incident and CAPA metrics; and Develop incident notifications and safety alerts. Completes tasks to support environmental compliance with site air, waste, water programs, including compliance samples, reviews, and compiles data, and prepares regulatory reports. You will report to the Associate Director of EHS and not have any direct reports. You will be located on-site in our Kankakee manufacturing facility. Qualifications: • Bachelor degree in Occupational Safety, Environmental Engineering, Environmental Sciences, Chemical Engineering or equivalent • 5+ years' relevant experience including experience at a manufacturing site • Thorough knowledge of safety and environmental regulations • Large pharmaceutical or chemical manufacturing experience 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!