Specialist III – Quality Assurance, Systems

Specialist III – Quality Assurance, Systems

Position Summary:

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 to join our team. This role is accountable for the Investigation and CAPA Management Systems. You will manage complex and high-level deviations, support Out-of-Specification investigations, and collaborate with internal stakeholders to ensure effective execution of these systems. The position also focuses on maintaining and improving Quality Systems, reporting metrics, and implementing process enhancements to support compliance and operational excellence.

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!  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 to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

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