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Quality Systems Associate - Training and Deviations/CAPAs

Marin Metro Area, CA

Post Date: 12/05/2017 Job ID: JN -122017-20542 Job Type: Quality Assurance - Scientific
DUTIES:
  • 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.
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.
EXPERIENCE / EDUCATION:
  • Minimum 5 years experience with GxP environment
  • Associates degree or higher

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