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This role will provide Quality Assurance oversight for the execution of the Deviation and CAPA Management process for internal GMP operations at both the Gene Therapy Manufacturing Facility (GTMF) located in Bedford, MA and the Quality Control Laboratories located in Woburn, MA. This role will ensure Deviations and CAPA are executed in a robust manner to prevent recurrence of nonconformances by driving to root cause and establishing effective CAPA. This role will assess and improve maturity of the Deviation and CAPA process using various techniques such as trend analysis, review of establish metrics, and auditing of records. The role will also support Deviation and CAPA training. This position will work closely with Manufacturing, (Local) Supply Chain / Warehouse, Facilities, Engineering, Quality Control, and MSAT.
