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Stability Scientist

Alpha Consulting Corp., DEVENS massachusetts

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STABILITY ASSOCIATE SCIENTIST
DEVENS, MA

  • Develop stability product requirements for annual enrollments, process changes and investigations. Determine the stability requirements for commercial products, based on technical rationale and globally approved dossiers. Maintain a list of required yearly stability enrollments.
  • Perform change control impact assessments and document the stability assessment in change controls. Review and endorse change controls as an expanded reviewer. Initiate change controls related to stability operations as necessary.
  • Represent GPS on laboratory and manufacturing investigation teams by performing stability impact assessments.
  • Knowledge of US/EU/ROW Requirements, Corporate Directives and industry best practices; develops strategies for solving complex problems/issues; recommending and driving implementation of solutions. Use computer software/programs: Microsoft Office applications, SAP, LIMS, Trackwise, JMP, etc.
  • Minimum of - 2 years (PhD)/ 6-8 years (MS)/ 8-10 years (BS) relevant cGMP experience in biopharma at Client or other company.
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