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The GMP Systems group is a compliance function within the Cellular Processing Facility (CPF). The CPF is a manufacturing organization that executes process operations in the production of modified cellular products for patients participating in cell therapy clinical trials in the Fred Hutch Cancer Research Center. GMP Systems is responsible for developing and administrating a variety of quality systems to ensure compliance with applicable regulations. The groups focus is on all aspects of GMP equipment life cycle, as well as on raw materials inventory management.
The GMP Systems Specialist II will primarily address facilitation of process equipment commissioning and qualification, routine calibration, maintenance, and repairs of GMP manufacturing and laboratory equipment to ensure a continued state of regulatory compliance and continuity in support of clinical manufacturing operations.