QC Validation Consultant

  • Rensselaer, NY
  • Posted 5 hours ago | Updated 5 hours ago

Overview

On Site
Depends on Experience
Contract - W2
Contract - Independent
Contract - 12 Month(s)

Skills

Agile
Change Control
Computer Networking
Data Integrity
Health Care
Life Sciences
Pharmaceutics
Quality Assurance
Quality Control
Regulatory Compliance

Job Details

Job Title : QA/ QC/Validation
Location : Rensselaer, NY
Duration : 12+ Months Contract
Job Description
QA/ QC/Validation with benchtop instrument
  • 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
Qualifications:
  • Prior experience with benchtop instrument experience is a must
  • Bachelor s/ Master s degree or equivalent in a scientific or health care field.
  • 5+ years' experience in a Validation/ Quality assurance / control role, preferably in the pharmaceutical /Life sciences industry preferred.
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