Quality Assurance Specialist - Biomanufacturing Facility

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The Cedars-Sinai Biomanufacturing Center (CBC) is a state-of-the art facility that comprises of a cGMP cell manufacturing facility housing multiple cleanroom cell production suites and process development rooms for producing the next generation of cell and gene therapies. With world class expertise in stem cell (iPSC) biology, bioprocessing, translational, regulatory and manufacturing, Cedars-Sinai is committed to pushing the frontiers of medicine and discovering new technologies and innovations that will impact how we diagnose and treat disease.

To learn more about the CBC, please visit: GMP Biomanufacturing Services | Cedars-Sinai (cedars-sinai.org)

The Quality Specialist conducts work assignments of increasing complexity, under moderate supervision with some latitude for independent judgment; and with a team to implement inspection plans, quality plans, support auditing functions, and/or evaluate supplier performance. 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. The Quality Specialist will ensure the quality assurance of clinical manufacturing for quality standards of final cell products and 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. All aspects of systematic monitoring and evaluation of the various activities being performed in the cGMP cell manufacturing that appropriate standards of quality are attained and to assure that products are required quality for their intended use.

Primary Duties and Responsibilities:

• Assists in the second-level QA subject matter expert/enforcement review of processes in compliance with quality procedures; overall objective of review for investigation
• Measures and evaluates supplier quality and delivery performance; maintains supplier quality record files; maintains supplier approval status.
• Collects and reviews defect data contained in non-conformance forms, summarized defect data and publishes trend charts and corrective action status and effectiveness
• Assists with document control and records management
• Serve as SME on the use of risk-based tools for qualification, training, monitoring and disqualification
• Assess and approve any changes to cGMP-systems to assure validated state of the systems is maintained
• Create and or maintain standardized templates for documents, forms, and similar to provide consistent finished product
• Point of contact for Processing Change Orders (CO)