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Quality Systems Supervisor, Site Quality Assurance Operations
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Full-time
- Specific responsibilities include but are not limited to Quality support/oversight and leading initiatives related to: tech transfer and facility start-up, floor operations, QMS record review, MBR and SOP generation/revision, training, materials management, equipment management, and maintenance at the Editas Waltham and Editas Devens GMP manufacturing facilities.
- Support Editas' clinical cell manufacturing facilities in Waltham, MA and Devens, MA as a member of the Quality Operations team with primary focus on QMS records and technical reviews related to both Manufacturing and Quality Control.
- Author, review and/or approve GMP documentation (SOPs, batch records, protocols, technical reports, test methods, protocols, specifications, and summary reports to support GMP manufacturing and QC testing).
- B.S., M.S., with 6-8 years of experience or PhD in a scientific discipline with 1+ years of experience as a Quality professional in the biopharmaceutical industry
- Experience supporting cGMP biologics manufacturing required.
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