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Quality Senior Specialist

  • Location: Boston
  • Salary: £40 - £45.00 per hour per hour
  • Job Type:Contract

Posted 17 days ago

  • Sector: Life Sciences
  • Contact: Lucia Mytlewska- McDonald
  • Duration: 6 months
  • Expiry Date: 19 October 2022
  • Job Ref: JN -092022-473670

Job description:

  • 6 Month Contract
  • Works with a high degree of independence to provide QA Analytical support for release and stability program for commercial and clinical products. This role will review analytical data, deviations, change controls, and other quality systems documentation in support of product disposition and stability.
  • Reviews of analytical data for release and stability of Commercial and Clinical products including DS, DPI, DP and packaged goods. Reviews of analytical data associated to method validation and tech transfer activities
  • Generates and approve Certificate of Analysis
  • Supports Analytical Investigations, and Quality Events: Deviations, OOS Investigations, CAPA and change controls assessments. Leverage technical and compliance expertise to for root-cause analysis and product impact assessment.

Qualification:

  • Bachelor's degree in a scientific discipling, chemistry, engineering, or allied health field
  • 3+ years of relevant work experience, or comparable background.
  • Experience within QA/QC is preferred
  • Experience with supporting stability program is preferred.



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