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QC Stability Specialist

Cambridge, MA

Posted: 05/17/2022 Employment Type: Contract Job Category: Clinical: Quality Job Number: 3110

Job Description

  • Execute day to day operations of the stability activities through sample receipts, aliquoting, stability sample set-down, data compilation.
  • Responsible for authoring of stability protocols to establishing our Internal stability management capabilities.
  • Provide oversight to CMOs/CTLs to ensure that studies conducted externally are executed compliantly and studies are set down on time
  • Responsible for entering stability data into slide decks, and spreadsheets
  • Responsible for the resolution and on-time completion of stability-related deviations, CAPAs, and Change Controls by providing technical expertise, as appropriate.
  • Responsible for managing the shipment of stability materials to different sites as needed
  • Responsible for generating, updating, and stability-related SOPs, as appropriate.
  • Responsible for ensuring that the stability-related forms / documents adhere to GXP requirements and internal SOPs.
  • Other duties as assigned.

Requirements / Qualifications:
  • 2-5 years’ experience in a GxP environment
  • Bachelors in a Life Science
  • Scientific background in Stability or Analytics for Biologics
  • Experience with LIMS preferred
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