What are the responsibilities and job description for the QA Validation Specialist - Cell and Gene Therapy position at BioPharma Consulting JAD Group?
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