Quality Systems Support Associate
San Rafael, California | Contract
Our client focuses on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.
- 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.
- Support the FVIII production/project for deviations, discrepancies and training item build for QC.
- Record entry into Learning Management Systems.
- Assist with the development and administration of the training system for QC groups.
- Excellent with writing and reviewing skills.
- 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.
Associates degree or higher
Minimum 5 years experience with GxP environment