Quality Assurance Specialist

The Quality Assurance Specialist is responsible for supporting quality systems and ensuring compliance with established procedures, regulatory requirements, and applicable quality standards. This role works closely with Quality Assurance, Quality Control, Operations, and Manufacturing teams to investigate quality events, identify root causes, review batch documentation, and support continuous improvement initiatives. Key Responsibilities Serve as the Quality Assurance representative in Root Cause Analysis (RCA) activities supporting deviation investigations of moderate to high complexity. Participate in deviation investigations, assess quality impact, and support the identification and implementation of appropriate corrective and preventive actions (CAPA). Perform thorough quality batch record reviews to ensure completeness, accuracy, consistency, and compliance with approved procedures and specifications. Review manufacturing and operational documentation for adherence to Good Manufacturing Practices (GMP) and applicable quality requirements. Collaborate with Operations, Manufacturing, Quality Control, Engineering, and other cross-functional teams to resolve quality issues. Maintain current knowledge of applicable GMP requirements, quality systems, and company procedures. Required Qualifications Bachelor’s degree required, preferably in Technology, Engineering, Microbiology, or a related scientific/technical field. Equivalent combinations of education, training, and relevant work experience may be considered. Minimum of 4 years of relevant experience, with previous experience in Quality Assurance, Quality Control, Operations, or Manufacturing. Experience participating in deviation investigations and Root Cause Analysis. Experience performing batch record review and evaluating manufacturing documentation. Working knowledge of GMP principles, quality systems, and applicable regulatory requirements. Experience in a regulated manufacturing environment, preferably pharmaceutical, biotechnology, medical device, or other life-science industries. Experience with formal Root Cause Analysis methodologies and CAPA processes. #J-18808-Ljbffr