Specialist III – Quality Assurance, Systems Catalent

Ourlivesmadison; Madison, Northern (WI, KY); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health benefits from day one

Paid holidays

Tuition reimbursement

Job summary

Catalent in Madison, Wisconsin seeks a Specialist III – Quality Assurance, Systems to lead investigations, manage CAPAs, and ensure robust quality systems on-site. The role involves client interactions, document control, and process improvements to sustain compliance and operational excellence.

The ideal candidate holds a STEM degree with extensive related experience and will advance quality systems, metrics, and training across the team at the Madison GMP facility.

Qualifications

• Doctorate degree in a STEM discipline with extensive related experience.
• Master’s degree in a STEM discipline with substantial related experience.
• Bachelor’s degree in a STEM discipline with significant related experience.
• Associate’s degree in a STEM discipline with many related years of experience.

Responsibilities

• Quality review and approval on deviations, investigations and complaints.
• Oversee 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.

Education

Doctorate Degree in a STEM discipline

Master’s Degree in a STEM discipline

Bachelor’s Degree in a STEM discipline

Associate’s Degree in a STEM discipline

Job description

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 aSpecialist III – Quality Assurance, Systemsto 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.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [e-mail]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.