QA Validation Specialist - Cell and Gene Therapy
Summary
QA Validation Specialist providing quality oversight of commissioning, qualification and validation at a cGMP cell and gene therapy manufacturing facility and QC labs in Boston. Day to day involves reviewing/approving IQ/OQ/PQ, CSV, process and cleaning validation documents, CMMS records, and SOPs in Veeva, plus supporting change controls, deviations and audits on a 6-12 month contract.
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
Skills
As published by workable · 5 questions · 1 written answer
Basics
First name, Last name, Email, Headline, Phone, Address, Photo, Education, Experience, Summary, Resume, Cover letter
Short answers (1)
- What is your expected hourly pay rate (USD/hr)?
Pick from a list (3)
- Are you legally authorized to work in the United States?
- Can you work in the United States without needing visa sponsorship, now or in the future?
- Do you have Kneat experience?
Written answers (1)
- How many years of validation or QA validation experience do you have?