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BioPharma Consulting JAD Group
QA Validation Specialist - Cell and Gene Therapy
Boston, Massachusetts, United StatesOn-siteContractVertex
Salary not posted. The employer did not include pay in this listing. Ask for the range in your first conversation; it is a fair question.
Posted Today · listed on Workable
Should you apply?
- Open
- 1 day
- Fresh. First-week applicants get read first.
- Open roles at this company
- 16
- A few open seats. Your application will get a real look.
- Salary
- Not posted
- No range in the posting. Ask early. It is a fair question and it saves everyone time.
Days open comes from the posting date. Fill time and reposting rate come from this company's recent public postings.
About the 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.
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