Quality Assurance Associate

QA Operations Specialist Key Accountabilities Understand and adhere to GMP policies. Prepare, review, and maintain quality documents within the QMS (MasterControl), including document control and lifecycle support. Support training management; ensure training matrices and records are accurate and up to date in the QMS. Support internal/external audits, supplier quality activities, and CMO oversight (document reviews, audit participation, quality agreements). Assist functional areas to achieve timely and compliant final product dispositions. Write, implement, and approve Deviations, Investigations, CAPA, change control, and complaint reports; ensure timely, compliant closure. Ensure site personnel compliance, application of aseptic techniques, and compliance to sterile manufacturing regulations. Participate in supplier/vendor assurance and supplier quality agreements. Lead FDA/Regulatory interactions for Angleton site activities to support successful submissions and inspections. Perform QA Operations as a business partner focused on safety, quality, delivery to patients, cost, compliance, and data integrity. Collaborate with manufacturing, supply chain, and cross‑functional teams on batch review/release and continuous QMS improvement. Education and Experience / Requirements Bachelor’s degree in Life Sciences, Quality Management, or related field. 3+ years in quality assurance. Experience in GxP sterile manufacturing operations. Cross‑functional collaboration experience. Ability to work in a team environment and communicate effectively. Willingness to work with radioactive materials and follow strict safety protocols. Technical understanding of manufacturing, quality, and regulatory requirements. Experience writing/reviewing SOPs and specifications. Key Capabilities Inclusive mindset Creativity/innovation Commitment to excellence Results‑oriented Ethical behavior Adaptability Strong communication Collaboration Resilience Continuous learning #J-18808-Ljbffr