Specialist III - Quality Assurance

**Specialist III- Quality Assurance** **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 a Specialist III - Quality Assurance.** 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 representing Quality Assurance in support of complex Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution. - Lead continuous improvement projects for the Quality Assurance Operations department. - Accountable for review of Master Batch Production Records and material specifications for prepared solutions and columns. - Responsible for oversight of the control and management of Cell Bank inventory. - Provides review and approval of protocols and associated executed reports supporting Manufacturing operations, including media process simulations. - Responsible for review and approval deviation investigation records. - Develops and provides training to Quality Assurance and Manufacturing personnel on Quality topics. - Maintains a sufficient understanding of the quality systems and operations to provide consultation and guidance for Manufacturing personnel regarding execution of the Quality Management Systems. - All other duties as assigned **The Candidate:** - Doctorate Degree in STEM discipline with minimum of 6 years related experience. OR - Master's Degree in STEM discipline with minimum of 8 years related experience. OR - Bachelor's Degree in STEM discipline with minimum of 10 years related experience. OR - Associates Degree in STEM discipline with minimum of 14 years related experience. - Prior work experience with quality management software such as TrackWise® or ComplianceWire®. **Why you should join Catalent:** - Defined career path and annual performance review and feedback process - Diverse, inclusive culture - Positive working environment focusing on continually improving processes to remain innovative - Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives - 152 hours of PTO + 8 paid holidays - Generous 401K match - Medical, dental and vision benefits effective day one of employment - Tuition Reimbursement - Let us help you finish your degree or start a new degree! **Catalent offers rewarding opportunities to further your career!** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit [Catalent Careers](https://careers.catalent.com/us/en) to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodatio…