QA Validation Specialist - Cell and Gene Therapy

Biopharma-Consulting-Jad-Group; Boston (MA); On-site; USD 83,000 - 124,000; Full time

Job summary

Biopharma-Consulting-Jad-Group in Boston, MA is seeking a QA Validation professional to oversee commissioning, qualification and validation for a cGMP cell and gene therapy manufacturing facility and QC laboratories.

You will review validation protocols, SOPs, and CMMS records, while supporting change controls, deviations, audits, and inspections. A technical bachelor’s degree with 5+ years in validation/QA is required and Kneat is strongly preferred.

Qualifications

• Bachelor's degree in a technical discipline; 5 years of validation/QA experience or 7+ years equivalent.
• Knowledge of 21 CFR, ICH, EU regulations, GAMP 5 and risk-based validation.
• Kneat strongly preferred; experience in cell and gene therapy or contract manufacturing is a plus.

Responsibilities

• 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.

Skills

CQV knowledge

QA experience

GMP knowledge

Education

Bachelor's degree in a technical discipline

Tools

Kneat

Veeva

CMMS

Job 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.

• 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.

• Contract: 6–12 months, with possible extension
• Shift: Administrative, Monday–Friday
• Start: Immediate