QA Validation Specialist - Cell and Gene Therapy
BioPharma Consulting JAD Group•Boston, MA
•Onsite
About The Position
Join a growing QA Validation group at a leading biotechnology company in Boston, Massachusetts. The QA Validation Specialist provides quality assurance oversight of commissioning, qualification, and validation (CQV) for a cGMP cell and gene therapy manufacturing facility and its QC laboratories. This is a 6–12 month contract with a possible extension, on an administrative Monday–Friday shift, with an immediate start.
Requirements
- Bachelor's degree in a technical discipline and 5 years of validation and/or QA experience, or 7 or more years of equivalent experience.
- Knowledge of 21 CFR, ICH, EU regulations, GAMP 5, and risk-based validation.
Nice To Haves
- Kneat experience.
- Cell and gene therapy or contract manufacturing experience.
Responsibilities
- Provide QA oversight of CQV, periodic review, and requalification.
- Review and approve validation protocols and reports, including IQ, OQ, PQ, CSV, process validation, 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.
