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Associate I, Quality Assurance

2 months ago

Waltham, United States ElevateBio Full time

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. The Role: ElevateBio is looking for an Associate I, QA Operations to join their growing Quality Group at our BaseCamp facility in Waltham, MA. In this role, the Associate I 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. Here’s What You’ll Do: Conduct thorough reviews of batch records, ensuring adherence to established procedures, specifications, and regulatory requirements. Verify that validated processes are consistently followed on the manufacturing floor. Document activities clearly and concisely using strong technical writing skills. Perform review of work orders and OOT reports for equipment/ utilities. Perform visual inspection of final product. Foster clear communication with colleagues across departments, both verbally and in writing. Maintain a strong working knowledge of our Quality Management System (QMS) and relevant GxP regulations. Perform quality walk-throughs and process observations. Perform receipt and disposition of incoming patient apheresis material. Perform issuance verification of production documents and labels, to meet production schedule. Ensure timely resolution and escalation of issues within the operational areas. Identify compliance risks and escalate the issues to appropriate levels of management for resolution. Provide on-the-floor QA oversight and support in the GMP cleanroom to ensure Compliance to GMP regulations throughout the manufacturing areas. Requirements: Holds a Bachelor's degree in a relevant scientific field (or) an Associate's degree with a minimum of 2 years of experience in a QA/QC laboratory or manufacturing setting. Possesses a keen eye for detail and a commitment to upholding the highest quality standards. Demonstrates strong problem-solving skills and the ability to think critically. Has a passion for learning and staying up-to-date on regulatory requirements. Thrives in a fast-paced, collaborative environment. Experience working in a GxP manufacturing environment. Familiarity with specific GxP regulations (e.g., cGMP, ICH guidelines). Prior experience with deviation and non-conformance management. Why Join ElevateBio? ElevateBio 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. We aim to be the dominant engine inside the world’s greatest scientific advancements harnessing human 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 Vision: We 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. ElevateBio 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.

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