QA Validation Specialist - Cell and Gene Therapy

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 requalificationReview and approve validation protocols and reports (IQ, OQ, PQ, CSV, process and cleaning validation)Review CMMS records for asset release, database requests and work ordersAuthor and review SOPs in VeevaSupport 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 validationKneat strongly preferredCell and gene therapy or contract manufacturing experience preferred Benefits Contract: 6-12 months, with possible extensionShift: Administrative, Monday-FridayStart: Immediate