{"schemaVersion":"jobsearcher.job.v1","id":"15d45f19d4ec2d2d91d0428f","url":"https://jobsearcher.com/jobs/15d45f19d4ec2d2d91d0428f","canonicalUrl":"https://jobsearcher.com/jobs/15d45f19d4ec2d2d91d0428f","title":"Associate II, QA Operations (Contract)","description":"ElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to their full potential.\nThe Role:\nElevateBio is looking for an Associate II, QA Operations to join their growing Quality Group at our BaseCamp facility in Waltham, MA. In this role, the Associate II will be primarily responsible for providing Quality oversight over execution of clinical cell and gene therapy manufacturing for cGMP compliance through on the production floor interactions, review and approval of batch related documents, and events. This individual will engage with other members within operational departments as a Quality partner by providing real-time support in order to achieve on-time closure of quality records. A successful candidate in this position will effectively execute defined assignments, knowledgeable of cGMP best practices, applies knowledge to troubleshoot using source documentation, and proactively seeks resources to build on own experience.\nHere's What You'll Do:\nProvide on-the-floor QA oversight and support in the GMP cleanroom to ensure compliance to GMP regulations throughout the manufacturing areas.\nPerform quality walk-throughs and process observations.\nPerform receipt and disposition of incoming patient apheresis material.\nPerform issuance verification of production documents and labels, to meet production schedule.\nEnsure timely resolution and escalation of issues within the operational areas.\nEnsure all product-related Deviations are initiated, investigated, and resolved.\nOwnership and investigation minor/ major deviations.\nPerform Batch Record and Logbook review.\nPerform review of work orders and OOT reports for equipment/ utilities.\nPerform visual inspection of final product.\nIdentify compliance risks and escalate the issues to appropriate levels of management for resolution.\nRequirements:\nBA/BS degree with a minimum of 3 years of experience in a pharmaceutical, biotechnology or biologics operation.\nExperience in Viral Vectors, Cellular and Gene Therapy Products is desired.\nWorking knowledge and ability to apply GMPs.\nStrong teamwork and collaborative skills.\nExperience with manufacturing investigations, deviations, and CAPA.\nStrong knowledge with aseptic manufacturing processes is preferred.\nExperience in electronic Enterprise Management systems, Quality Management Systems, Document Management Systems.\n\nWhy Join ElevateBio?\nElevateBio is a technology-driven company built to power transformative genetic medicines today and for many decades to come. The 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 next-generation, full-spectrum gene editing platform; comprehensive cell engineering technologies; and an expanded viral and non-viral therapeutic delivery platform – with BaseCamp®, its end-to-end genetic medicine cGMP manufacturing and process development business, to accelerate the discovery and development of advanced therapeutics.\nWe aim to be the dominant engine inside the world's greatest scientific advancements harnessing human cells and genes to alter disease.\nOur Mission:\nTo power the creation of life-transforming cell and gene therapies, at a speed the world deserves.\nOur Vision:\nWe seek 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.\nElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.","company":"Elevatebio","rawCompany":"elevatebio","city":"Waltham","state":"MA","isRemote":false,"isActive":false,"createdAt":"2026-04-12T21:07:00.392Z","occupations":[{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"},{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"},{"code":"51-9061.00","title":"Inspectors, Testers, Sorters, Samplers, and Weighers","slug":"inspectors-testers-sorters-samplers-and-weighers"}],"industries":[{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"},{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"},{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Associate II, QA Operations (Contract)","description":"ElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to their full potential.\nThe Role:\nElevateBio is looking for an Associate II, QA Operations to join their growing Quality Group at our BaseCamp facility in Waltham, MA. In this role, the Associate II will be primarily responsible for providing Quality oversight over execution of clinical cell and gene therapy manufacturing for cGMP compliance through on the production floor interactions, review and approval of batch related documents, and events. This individual will engage with other members within operational departments as a Quality partner by providing real-time support in order to achieve on-time closure of quality records. A successful candidate in this position will effectively execute defined assignments, knowledgeable of cGMP best practices, applies knowledge to troubleshoot using source documentation, and proactively seeks resources to build on own experience.\nHere's What You'll Do:\nProvide on-the-floor QA oversight and support in the GMP cleanroom to ensure compliance to GMP regulations throughout the manufacturing areas.\nPerform quality walk-throughs and process observations.\nPerform receipt and disposition of incoming patient apheresis material.\nPerform issuance verification of production documents and labels, to meet production schedule.\nEnsure timely resolution and escalation of issues within the operational areas.\nEnsure all product-related Deviations are initiated, investigated, and resolved.\nOwnership and investigation minor/ major deviations.\nPerform Batch Record and Logbook review.\nPerform review of work orders and OOT reports for equipment/ utilities.\nPerform visual inspection of final product.\nIdentify compliance risks and escalate the issues to appropriate levels of management for resolution.\nRequirements:\nBA/BS degree with a minimum of 3 years of experience in a pharmaceutical, biotechnology or biologics operation.\nExperience in Viral Vectors, Cellular and Gene Therapy Products is desired.\nWorking knowledge and ability to apply GMPs.\nStrong teamwork and collaborative skills.\nExperience with manufacturing investigations, deviations, and CAPA.\nStrong knowledge with aseptic manufacturing processes is preferred.\nExperience in electronic Enterprise Management systems, Quality Management Systems, Document Management Systems.\n\nWhy Join ElevateBio?\nElevateBio is a technology-driven company built to power transformative genetic medicines today and for many decades to come. The 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 next-generation, full-spectrum gene editing platform; comprehensive cell engineering technologies; and an expanded viral and non-viral therapeutic delivery platform – with BaseCamp®, its end-to-end genetic medicine cGMP manufacturing and process development business, to accelerate the discovery and development of advanced therapeutics.\nWe aim to be the dominant engine inside the world's greatest scientific advancements harnessing human cells and genes to alter disease.\nOur Mission:\nTo power the creation of life-transforming cell and gene therapies, at a speed the world deserves.\nOur Vision:\nWe seek 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.\nElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.","datePosted":"2026-04-12T21:07:00.392Z","dateModified":"2026-04-12T21:07:00.392Z","hiringOrganization":{"@type":"Organization","name":"Elevatebio","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Waltham","addressRegion":"MA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"15d45f19d4ec2d2d91d0428f"},"url":"https://jobsearcher.com/jobs/15d45f19d4ec2d2d91d0428f"}}