Quality Assurance Lead - Biomanufacturing Center

In the Cedars-Sinai Biomanufacturing Center (CBC), o ur mission is to accelerate scientific discovery by generating world-class biomaterials and conducting groundbreaking research in biobanking, personalized medicine and stem cell biology. For more information on the CBC, please visit https://www.cedars-sinai.org/research/areas/biomanufacturing.html .

As a Quality Assurance Lead in the CBC, you will conduct complex work under minimal supervision and with wide latitude for independent judgement. This role oversees a team to implement inspection plans, quality plans, support auditing functions, and/or evaluate supplier performance.

Additional Job Duties and Responsibilities:

• Contributes to the planning, implementation, and administration of cost-effective Quality Programs, assuring that a system is in place which will meet contractual quality requirements.
• Responsible for overseeing quality assurance of clinical manufacturing for quality standards of final cell products.
• Identifies and assesses quality risk in activities and processes per regulatory guidelines, cGMPS, and standard operating procedures.
• Responsible for ensuring compliance with all Federal and State laws and regulations and other accrediting agency requirements in the collection, processing, preparation, and distribution of biopharmaceutical products manufactured in the cGMP facilities of the CBC.
• Responsible for all aspects of systematic monitoring and evaluation of the various activities being performed in the cGMP cell manufacturing.
• Ensures that appropriate standards of quality are attained and that products are required quality for their intended use.

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