Quality Systems Associate - Training and Deviations/CAPAs
Marin Metro Area, CA
- Review and closure of QC discrepancy reports within specified timelines:
- EM excursions
- Laboratory deviations
- Laboratory investigation reports
- Out of specification/trend reports.
- Provide technical expertise and knowledge to QC support group in determining root causes and developing effective CAPAs.
- Reviewing compendial updates and evaluating current QC practice compliance.
- Providing departmental metrics.
- Assisting with the closure of departmental Change Requests.
- Training record GDP review and resolution.
- Assist in the investigation of training discrepancies.
- Record entry into Learning Management Systems.
- Assist with the development and administration of the training system for QC groups.
- Knowledge of discrepancy records (deviations, laboratory investigation reports, out of specification, out of trend) for assignable root cause, development of appropriate CAPAs, and evaluation of CAPA effectiveness a plus.
- Knowledge of Learning Management Systems and other QC information systems (such as Trackwise, ComplianceWire, document control systems).
- Experience with compendial updates and compliance.
- Meticulous record keeping skills, excellent attention to detail.
- Knowledge of cGMPs and regulations applicable to the FDA and comparable international regulatory agencies a plus.
- Minimum 5 years experience with GxP environment
- Associates degree or higher