Specialist III – Quality Assurance, Systems

Catalent•Madison, WI

2d•Onsite

About The Position

The Specialist III – Quality Assurance, Systems is accountable for the Investigation and CAPA Management Systems at Catalent’s Madison, Wisconsin biologics development and manufacturing site. The position 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. The role is based 100% on-site and follows a Monday–Friday, 8:00 a.m.–5:00 p.m. schedule. Catalent’s Madison facility supports biologics development and clinical manufacturing, including mammalian cell line engineering, drug substance biomanufacturing, and biopharmaceutical development.

Requirements

Doctorate degree in a STEM discipline and a minimum of 6 years of related experience; or a master’s degree in a STEM discipline and a minimum of 8 years of related experience; or a bachelor’s degree in a STEM discipline and a minimum of 10 years of related experience; or an associate 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.
Maintain and improve Quality Systems, report metrics, and implement process enhancements.
Perform other duties as assigned.