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Job opportunity
QA Validation Specialist - Cell and Gene Therapy
BioPharma Consulting JAD Group
Boston, MA, US
Source: BioPharma Consulting JAD Group careers · View original posting
- Employment
- contract
Employer job description
From BioPharma Consulting JAD Group's posting. “We” and “our” refer to the employer.
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
About this listing
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