JVT Advisors

Specialist, External Quality Assurance, Batch Disposition, 1st Shift (2)

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Location: Norwood, Massachusetts 02139
Employment Type: Contract

Job Description

Contract Length: 6 months

Job Summary: The individual in this role will be responsible for providing Quality support in batch disposition related to external aseptic fill/finish activities.

Responsibilities:

  • Perform all activities required for commercial and clinical batch disposition
  • Review batch records, associated testing records, and other documentation to ensure that all steps have been executed correctly, verified where applicable, and that all limits and specifications have been met
  • Review batch records, associated testing records, and other documentation to ensure that all steps have been executed correctly, verified where applicable, and that all limits and specifications have been met
  • Support Manager to collect and report targeted metrics for Management Review
  • Support Quality Agreement review with contract manufacturers
  • Review protocols, analytical results, and documents associated with investigations, OOS results, etc., and corrective/preventive action plans
  • Collaborate with Manufacturing and lead investigation teams to resolve equipment and process related deviations

Requirements:

  • BS with at least 4 years of experience, or a Master’s level degree and 2 years’ experience in the pharmaceutical/biotech industry
  • Working knowledge of relevant FDA, EU, ICH guidelines and regulations.
  • Experience working with CMOs, vendors, and relationship management preferred.
  • Experience working with aseptic fill and finish of vials preferred.
  • Familiarity with PDA Technical Reports 22, 26, 60, and 79 preferred

Trevor Hoffman

Technical Recruiter

Trevor recruits for JVT's Life Sciences and Technology Practices where he specializes in finding, screening, and placing top-tier industry innovators at companies across multiple markets and verticals.

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