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Specialist- Testing Support, Release & Stability Laboratory
at Vertex Pharmaceuticals Inc (US)
Boston, MA

Specialist- Testing Support, Release & Stability Laboratory
at Vertex Pharmaceuticals Inc (US)
Boston, MA

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Description

This role provides testing support for Release and Stability Laboratory (RSL) department supporting validation, testing and reporting of in-process, release and stability samples. Specific assigned persons are responsible to ensure activities occur in an efficient and cGMP compliant manner while fostering the Vertex vision and values.

KEY RESPONSIBILITIES:

  • Perform in-process, release, and stability testing independently following established methodology, procedures and SOPs
  • Participate in executing method validations and/or method transfers
  • Troubleshoot analytical methods with the assistance of supervisor when necessary
  • Maintain accurate testing records and adhere to cGMP/GDP expectation
  • May be required to author and review data, SOPs, analytical methods, protocols and reports
  • Participates in compliance related teams working towards the goal of continuous improvement.

EDUCATION AND EXPERIENCE:

  • A minimum of a Bachelor Degree in science or related discipline is required.
  • 6+ years of experience in GMP pharmaceutical/biopharmaceutical industry with at least 2 years of method validation/transfer experience.
  • Knowledge of US and EU cGMP regulations/guidance and some experience with regulatory agency inspections.
  • Strong knowledge of analytical methodologies such as chromatography, dissolution, and Karl Fisher and applying/interpretation of GMP requirements. Expertise with HPLC and/or GC is required.
  • The ability to work in a fast-paced environment, manage priorities and maintain timelines for multiple projects is essential.
  • Strong attention to detail
  • Effective communication skills, both verbal and written.

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