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QA Validation Specialist - Cell and Gene Therapy

BioPharma Consulting JAD Group · Boston, Estados Unidos Da América · On-site

  • Escritório em Boston
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Description

Join a growing QA Validation group at a leading biotechnology company in Boston, Massachusetts. You will provide QA oversight of commissioning, qualification and validation for a cGMP cell and gene therapy manufacturing facility and its QC laboratories.

What you'll do

  • Provide QA oversight of CQV, periodic review and requalification.
  • Review and approve validation protocols and reports (IQ, OQ, PQ, CSV, process and cleaning validation).
  • Review CMMS records for asset release, database requests and work orders.
  • Author and review SOPs in Veeva.
  • Support change controls, risk assessments, deviations, audits and inspections.

Requirements

  • Bachelor's degree in a technical discipline + 5 years of validation and/or QA experience (or 7+ years equivalent).
  • 21 CFR, ICH, EU regulations, GAMP 5 and risk-based validation.
  • Kneat strongly preferred.
  • Cell and gene therapy or contract manufacturing experience preferred.

Benefits

  • Contract: 6–12 months, with possible extension
  • Shift: Administrative, Monday–Friday
  • Start: Immediate