SpecialistI,QualityAssurance,DataReview

**Specialist I, Quality Assurance, Data Review** **Position Summary:** · **Work Schedule:** M-F 8am-5pm · 100% on-site Working for Catalent Biologics is an opportunity to join an entrepreneurial team. Catalent Biologics is making significant investments in people and capabilities. This is a unique opening to join a small, fast-growing business, backed by a global public company. People joining our team will have the opportunity for career development as our business continues to grow and expand. Catalent-Madison employees are helping to improve future patient outcomes by working on products that are designed to treat COVID-19, cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart, and lung diseases as well as Alzheimer’s. **Catalent Pharma Solutions in Madison, WI is hiring an Specialist I, Quality Assurance, Data Review.** The Quality Assurance department is responsible for all aspects of the quality assurance functions at Catalent, Madison. The department’s primary function is to ensure compliance with FDA and other regulatory agency requirements as well as internal quality systems requirements. This includes systems implementation and maintenance, documentation management, site-wide systems training, internal and external auditing, project review for accuracy and compliance, and material disposition. Quality Assurance safeguards all systems, processes, and actions to ensure regulatory compliance, which is essential in providing high quality drug products for our clients and their patients. The Quality Assurance Operations group has oversight of the manufacturing areas, including process technology transfer, master batch record review and approval, on-the-floor support, product disposition, and shipping. **The Role:** * Responsible for maintaining and enhancing the effectiveness of the Quality System through ensuring compliant preparation and execution of quality control operations. * Review analytical and microbiology data and documentati