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The GMP Systems Specialists group is a compliance function within the Cellular Processing Facility (CPF) that supports the manufacture of T-cell and stem cell therapeutic products for clinical trials. This group is responsible for developing and administrating a variety of quality systems to ensure compliance with applicable regulations, including facilitation of GMP equipment qualification, calibration/maintenance and repair, raw materials inventory management, training, cleanroom environmental controls, etc.
The GMP Systems Specialist will primarily focus on the facilitation of routine calibration, maintenance and repairs of GMP manufacturing and laboratory equipment to ensure a continued state of regulatory compliance and continuity of clinical manufacturing operations.