Specialist III – Quality Assurance, Systems

Catalent•Madison, WI

13d•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. 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.

Requirements

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

Responsibilities

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.