Specialist II QA Operations
Provides oversight for development and maintenance of quality programs, systems, processes and procedures to ensure compliance with company standards and regulatory guidelines. Leads preparation for audits/inspections and resolution of findings; liaises with auditing groups and inspectors throughout audits. Coordinates legal requests in support of government investigations or litigations. Ensures quality assurance programs and policies are maintained and modified regularly. Facilitates uniform standards worldwide, sharing of best practices, and achievement of the company's mission globally.
Under direct supervision, supports Quality Assurance activities to ensure compliancewith company and cGMP standards
Participates in investigation meetings with responsible department and any requiredsupport group(s)
Performs inspections and maintains quality records for analysis of raw materials,materials in process, and finished products
May conduct internal audits including audits of regulatory submissions
Assists in preparation for regulatory and customer inspections and participates ininspections to ensure quality standards
Executes training/awareness related to investigation and GMP changes to production team
Bachelor degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology,Biochemistry)
0-2 years’ experience working in a cGMP regulated environment
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About CSL Behring
CSL 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 us
As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.
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