US-GA, Supervisor, Quality Assurance SR0040630-MZ
Supervise and perform release of intermediate and final container product. Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines, and ensure all regulatory requirements for final container release are met according to the BLA.
Create and maintain final container release process and tracking metrics, develop process flow for meeting release timelines, and develop reports for effective release reporting.
Write APR (annual product review) reports for IGI and Albumin products.
This responsible person will use of Electronic Batch Management (EBM) and will also provide guidance to other team members.
Interacts frequently with functional superiors, peers, and provide coaching, training and development of subordinates.
The incumbent will be responsible to handle multiple projects, demonstrate effectiveness in task completion, decision-making, empowerment of others, exception management, training, problem solving and team leadership.
Ensure batch reviews and deviations reviews are performed in a timely manner to ensure on time release of batches.
Bachelors degree in Engineering, Science or related field or equivalent. Minimum of 4 years of QA experience in the life sciences and experience with a medical device / pharmaceutical or other similarly regulated industry preferred.
Must have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
Must demonstrate critical thinking skills and understanding of the manufacturing/Product Disposition processes and make Quality Decisions based on knowledge of regulations and regulatory trends.
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Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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