QA Validation Specialist - Cell and Gene Therapy

BioPharma Consulting JAD Group • Boston, MA

12h • Onsite

About The Position

Join a growing QA Validation group at a leading biotechnology company in Boston, Massachusetts. The role provides QA oversight of commissioning, qualification, and validation for a cGMP cell and gene therapy manufacturing facility and its QC laboratories.

Requirements

• Bachelor's degree in a technical discipline and 5 years of validation and/or QA experience, or 7+ years of equivalent experience.
• Knowledge of 21 CFR, ICH, and EU regulations, GAMP 5, and risk-based validation.

Nice To Haves

• Kneat experience is strongly preferred.
• Cell and gene therapy or contract manufacturing experience is preferred.

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.

What This Job Offers

• Career Level: Mid Level