Validation / Quality Assurance Analyst. Job at cGxPServe, Rensselaer, NY

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  • cGxPServe
  • Rensselaer, NY

Job Description

Responsibilities:
  • Create and support review of validation life cycle documents for Analytical.
  • Instrument Qualification and computerized systems.
  • Experience in validation of analytical instrument systems (e.g. benchtop analytical systems - spectroscopy, chromatography, protein analyzers, next gen sequencers, PCRs etc.).
  • Consult clients on data integrity requirements in Analytical Instruments and perform verification of DI in the systems.
  • Author validation life cycle documents for client's review and approval.
  • Route drafted documents for review.
  • Route reviewed documents for workflow approval.
  • Request approval workflows to Doc Control.
  • Execute approved protocols in GxP facility.
  • Understand SDLC process and SDLC methodology such as agile etc.
  • Work with different stakeholders (IT, Network, Vendor) team in delivering validation project deliverables.
  • Manage change controls necessary for project life cycle through process compliance and interface with Quality Assurance change control area.
  • Author change control documents for client review and approval.
Requirements:
  • Prior experience with benchtop instrument experience is a must.
  • Bachelor's/ master's degree or equivalent in a scientific or health care field.
  • 7+ years' experience in a Validation/ Quality assurance / control role, preferably in the pharmaceutical /Life sciences industry preferred.

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