Specialist, Quality Assurance

Specialist, Quality Assurance supports QA activities for pharmaceutical manufacturing, including review of batch records and product release decisions, drafting and review of SOPs and master batch records, ensuring compliance with FDA regulations, GXPs, and internal SOPs, and participating in QA program development, continuous improvement initiatives, and annual product reviews. On-site at Catalent's Kansas City facility, the role requires attention to detail, strong written and verbal communication, and ability to identify quality/compliance issues. Qualifications include a Master’s degree or Bachelor’s with 3+ years of QA experience (GMP environment) and knowledge of FDA regulations, batch record review, product release, and SOP drafting. The role emphasizes collaboration, regulatory compliance, and contribution to quality systems in a dynamic manufacturing setting.