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Sr. QA Specialist - Plant Operations
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- We at RoslinCT, are a world-leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change people’s lives.
- This includes developing QA specific procedures related to product disposition, line clearance and review and approval of GMP documentation including but not limited to Batch Records, Validation Protocols/Reports, and Calibration/Work Order Records and new equipment enrollment.
- Specialists will also assist, as required, with product receipt, shipment and disposition, line clearance and quality system review / approval in the QA role.
- Perform QA plant operations activities, including, but not limited to, review and approval of Batch Records, Validation Protocols/Reports, Calibration/Work Order Records and new material and equipment enrollment
- Work cross functionally and provide QA support for development, review and approval of procedures/workflows for manufacturing, Facilities/Validation and QC.
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