Associate I, Quality Operations

Role: QA Analyst I supporting Fort Worth North Manufacturing, responsible for product quality analysis, inspection, and ensuring compliance with cGMP standards and regulatory requirements. Responsibilities: review deviations, approve shipments under quarantine, perform routine testing of raw materials and finished goods, and support audits and validation activities. Also includes SOP revisions, production support, investigation resolution, and collaboration with operations to ensure high-quality product manufacture. Qualifications: typically requires relevant technical education, experience in quality assurance within biopharma manufacturing, and knowledge of systems such as Inventory, MES, Trackwise, and Laboratory Management. Preferred skills include familiarity with aseptic processes, validation, and regulatory standards (e.g., GMP, HSE). High-value specifics: biologics manufacturing at a sterile, aseptic facility; emphasis on microbiology, sterility assurance, and compliance audits; support for validation and media programs. Collaboration involves cross-functional teams including production, maintenance, and quality. Work setup is on-site in Fort Worth, Texas, with flexibility for production needs and overtime.