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Quality Control Senior Specialist
at Vertex Pharmaceuticals Inc (US)
Boston, MA

Quality Control Senior Specialist
at Vertex Pharmaceuticals Inc (US)
Boston, MA

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Description

Key Responsibilities:

  • Partner with cross-functional groups, including Quality Assurance, Supply Chain, Analytical Development, and Technical Operations Analytical in execution of job functions.
  • Technical review and reporting of commercial stability programs.
  • Technical review, reporting, and distribution of commercial reference standards.
  • Review of technical and compliant cGMP analytical data.
  • Analysis of cGMP samples utilizing various analytical techniques.
  • Laboratory documentation compliance review.
  • Monitor and report laboratory metrics.

Minimum Qualifications:

  • BS/MS and 4+ years of relevant work experience
  • Advanced knowledge of cGMP in a pharmaceutical setting
  • Proficient in basic analytical techniques in a QC/commercial setting (e.g. HPLC, dissolution, GC, KF, etc.), including method validation/transfer
  • Experience with both drug substance and drug product (oral solid dosage forms) analytical data
  • Must be a committed team player and collaborator
  • Additional Desired Skills:
  • Experience with computerized Quality Management Systems (e.g. LIMS, Document Control)
  • Experience with statistical programs (e.g. JMP)
  • Experience with electronic notebooks

Additional Desired Skills:

  • Experience with computerized Quality Management Systems (e.g. LIMS, Document Control)
  • Experience with statistical programs (e.g. JM)
  • Experience with electronic notebooks

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