QA Validation Specialist - Cell and Gene Therapy BioPharma Consulting JAD Group Boston, MA Job Details Contract 1 day ago Qualifications Pharmaceutical regulatory compliance ICH guidelines Production validation processes Bachelor's degree Quality assurance experience within pharmaceutical industry Risk assessment implementation FDA regulations Full 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. 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