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