|
Quality Assurance Specialist
- Perform technical review of cGMP documentation for completeness and compliance to cGMPs as outlined by governmental regulations and internal procedures.
- Provide advice and counsel on cGMP and related quality assurance issues to the value stream
- Demonstrated familiarity and compliance with cGMP's, EHS procedures and regulations, facility regulatory guidelines, and standard operating procedures.
- Provide on the floor QA support and perform QA Operations activities (batch record review and issuance, room release, line clearance, logbook and documentation review, aseptic processing oversight, etc)
- Take initiative to resolve quality documentation concerns (e.g., investigations, deviations, change controls, and other required documentation).
- Perform review and support regarding discrepancies and/or anomalies noted during QA review of associated processes. This includes deviation investigations, customer complaint investigations,
- Alert management of production trends which may serve as forewarning of process or equipment problems. As necessary, initiate investigations to address these issues.
- Write and/or revise controlled documents in support of job responsibilities.
- Routinely communicate and report deviations from procedures/processes to Quality Assurance Management and initiate appropriate action as necessary.
- Provide QA review and approval for Validation documents, PQRs and Change Controls
.
|
