Specialist III – Quality Assurance, Systems
• Work Schedule
M-F 8am-5pm
- 100% on-site
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. Located at 726 Heartland Trail in Madison, the approximately 102,700‑square‑foot GMP facility specializes in mammalian cell line engineering, drug substance biomanufacturing, and biopharmaceutical development, utilizing flexible single‑use systems to enable rapid scale‑up and customization. The site is home to Catalent's proprietary GPEx® and GPEx® Lightning technologies, which are used to generate high‑yielding mammalian cell lines for biologic therapies, and supports production scales ranging from 50 to 4,000 liters for clinical manufacturing. Following a $45 million expansion announced in 2025, the Madison site has significantly increased capacity, added new equipment, and created approximately 200 highly skilled biohealth jobs, further strengthening its role within Catalent's global biologics network and Wisconsin's growing life sciences ecosystem.
We have an opportunity for a Specialist III – Quality Assurance, Systems
The Role
- Perform quality review and approval on 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
- All other duties as assigned.
The Candidate:
- Doctorate Degree in a STEM discipline with a minimum of 6 years of related experience
- OR Master's Degree in a STEM discipline with a minimum of 8 years of related experience
- OR Bachelor's Degree in a STEM discipline with a minimum of 10 years of related experience
- OR Associate's Degree in a STEM discipline with a minimum of 14 years of related experience
Why you should join Catalent
- Defined career path with annual performance reviews and feedback process
- Diverse and inclusive culture
- Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
- Competitive paid time off plus 8 paid holidays
- Community engagement and green initiatives
- Medical, dental, and vision benefits effective day one of employment
- Tuition reimbursement
Catalent offers rewarding opportunities to further your career!
Volunteer Work Disclosure
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