Associate-QualityAssurance,OntheFloor(3rdShift)

**Associate I - Quality Assurance, On The Floor** **Position Summary:** * **Work Schedule: Sun - Wed 8PM - 6AM (3rd Shift)** * 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 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 a Associate I - Quality Assurance On The Floor.** 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 Role:** * Execute QA on the Floor program * Conduct manufacturing walkthroughs * Provide quality support to operations * Issue controlled production documents (e.g., batch records, labels) * Review batch records, test data, logs * Release solutions and materials * Inspect final product containers * Escalate quality/regulatory issues * Maintain controlled records. * Other duties as assigned. **The Candidate:** * Bachelor’s (STEM): 0+ years