Specialist III – Quality Assurance, Systems

Catalent Pharma Solutions • Madison, WI

3d • Onsite

About The Position

Catalent’s Madison, Wisconsin site is a state-of-the-art biologics development and manufacturing facility supporting customers from research through early- and mid-stage clinical production. This approximately 102,700-square-foot GMP facility specializes in mammalian cell line engineering, drug substance biomanufacturing, and biopharmaceutical development. It uses flexible single-use systems and supports clinical manufacturing scales from 50 to 4,000 liters. The site is home to Catalent’s GPEx® and GPEx® Lightning technologies. A $45 million expansion announced in 2025 increased capacity, added equipment, and created approximately 200 biohealth jobs.

The Specialist III – Quality Assurance, Systems is accountable for the Investigation and CAPA Management Systems. The role manages complex and high-level deviations, supports Out-of-Specification investigations, and collaborates with internal stakeholders to ensure effective execution of these systems. It also maintains and improves Quality Systems, reports metrics, and implements process enhancements to support compliance and operational excellence.

Requirements

• Doctorate degree in a STEM discipline and a minimum of 6 years of related experience; or
• Master’s degree in a STEM discipline and a minimum of 8 years of related experience; or
• Bachelor’s degree in a STEM discipline and a minimum of 10 years of related experience; or
• Associate’s degree in a STEM discipline and a minimum of 14 years of related experience.

Responsibilities

• Perform quality review and approval of deviations, laboratory investigations, and complaints.
• Oversee Corrective and Preventive Actions (CAPAs) opened in response to deviations.
• Address client comments on investigations.
• Participate in client calls to discuss investigation status.
• Engage in customer contact as required.
• Provide technical assistance and training for personnel.
• File and maintain controlled documents.
• Perform other duties as assigned.

Benefits

• Defined career path with annual performance reviews and feedback process.
• Diverse and inclusive culture.
• Potential for career growth on an expanding team.
• Competitive paid time off and 8 paid holidays.
• Community engagement and green initiatives.
• Medical, dental, and vision benefits effective on the first day of employment.
• Tuition reimbursement.

What This Job Offers

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