Quality Assurance Specialist

The Quality Assurance Specialist supports operations in a new Radiopharmaceutical facility in Indianapolis, IN, by providing quality oversight of shop floor activities, validation, and manufacturing operations to ensure compliance with GMP and regulatory requirements. Key Responsibilities Build and maintain cross‑functional relationships to improve processes and resolve issues. Provide quality oversight on manufacturing and validation activities. Ensure compliance with applicable procedural and protocol requirements. Perform real‑time review of manufacturing records. Perform periodic walkthroughs to ensure continued compliance with procedures. Maintain and update the training program as needed. Education / Experience / Skills BS/MS in a science‑related discipline (preferred). 3–5 years of quality assurance experience; experience in a GMP aseptic manufacturing environment preferred. Experience working with FDA or other federal and state regulatory bodies. Working knowledge of 21CFR Parts 11, 210, and 211. Highly motivated, organized, able to work independently. Excellent communication skills and professional ethics, integrity, and ability to maintain confidential information. EEO & Accessibility Statement BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. For additional information, visit careers.bms.com/eeo-accessibility. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. #J-18808-Ljbffr