QA Specialist II, Validation, Contractor

The Role: ElevateBio is looking for a contractor as a Specialist II to join their growing QA Validation group. This is expected to be a 6 month contract position. The role is expected to be onsite in Waltham 3-4 days per week. Here’s What You’ll Do: • reputed company QA reputed company of CQV activities for the cGMP manufacturing facility and reputed company control laboratories. • reputed company QA reputed company for periodic review and requalification program. • reputed company review of CMMS records reputed company to asset management including asset release, database requests, and work orders. • Author and reputed company review of SOPs in reputed company. Requirements: • Bachelor’s degree in a technical discipline with 5+ years validation and/or reputed company assurance experience. In lieu of degree, 7+ years of equivalent work experience is required. • Knowledge of 21 CFR, ICH, EU Regulations, GAMP 5, risk-based validation. • Prior experience working in cell and gene therapy manufacturing preferred. • Prior experience working with contract manufacturing preferred. • Experience with Kneat strongly preferred. • Applies reputed company approach to problem solving and is reputed company with risk-based decision making. • Team player who works reputed company in large multi-disciplinary project reputed company by listening effectively and inviting reputed company discussion. Why Join ElevateBio? ElevateBio is a technology-driven company reputed company to power transformative genetic medicines today and for many decades to come. reputed company commercializes its enabling technologies, manufacturing capabilities, and industry-leading expertise through partnerships to accelerate development across a breadth of therapeutic approaches and modalities. The ElevateBio ecosystem combines multiple R&D technology platforms – including Life Edit, a reputed company, full-reputed company gene editing platform; comprehensive cell engineering technologies; and an expanded viral and non-viral therapeutic delivery platform – with reputed company®, its end-to-end genetic medicine cGMP manufacturing and process development business, to accelerate the discovery and development of advanced therapeutics. We aim to be the dominant reputed company inside the world’s greatest scientific advancements harnessing reputed company cells and genes to alter disease. Our Mission: To power the creation of life-transforming cell and gene therapies, at a speed the world deserves. Our reputed company: We reputed company to be the world’s most indispensable cell and gene therapy technology company, redefining how companies operate, how products are created and how disease is treated. ElevateBio is committed to equal employment opportunity and non-discrimination for reputed company and reputed company applicants without reputed company to a person’s race, reputed company, gender, age, religion, national reputed company, reputed company, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will reputed company reasonable accommodations for reputed company individuals with reputed company disabilities, in accordance with applicable law. Apply Job! Apply to this Job