About this role
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.
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.
Contract: 6–12 months, with possible extension Shift: Administrative, Monday–Friday Start: Immediate