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Manager, Quality Control - Biomanufacturing Center
Cedars-Sinai Medical Center
With your help, we can change the future of healthcare! 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: https://www.cedars-sinai.org/research/areas/biomanufacturing/about.html Are you ready to be a part of groundbreaking research? The Quality Control (QC) Manager will provide quality control oversight of clinical manufacturing of final cell products and stage appropriate validation of analytical methods for cell therapy products. As a QC Manager, this role will be responsible for environmental monitoring, raw material testing, in-process and final product testing as well as for the purchase, installation and qualification of QC instrumentation. Additionally, the QC manager is responsible for establishing user requirements for purchase and qualification for analytical equipment, working with internal and external resources to maintain equipment in an optimal state. Review records and issue COAs for product release and develop, revise and review SOPs. Responsible for OOS investigations and participate in deviation investigations. The QC Manager will make certain that manufacturing performs efficiently, coordinate employee efforts when necessary, and facilitate communications between management and production departments. Primary Job Duties and Responsibilities:
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