Specialist III - Quality Assurance

Catalent • Madison, WI

4d • Onsite

About The Position

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.

Requirements

• 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®.

Responsibilities

• 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

Benefits

• 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!

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Associate degree