# QA Validation Specialist - Cell and Gene Therapy

**Company:** [BioPharma Consulting JAD Group](https://jobs.workable.com/companies/pScfjBzGATtPx3geL93jwD.md)
**Location:** Boston, United States
**Workplace:** on site
**Employment type:** Contract
**Department:** Vertex

[Apply for this job](https://jobs.workable.com/view/fa046724-c4b9-45a4-ad92-b3dbbfcc5df8)

## Description

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