Specialist III – Quality Assurance, Systems
Position Summary
Work Schedule: M-F 8am-5pm
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.
About the role
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.
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
Qualifications
- Doctorate Degree in a STEM discipline with a minimum of 6 years of related experience
- Master’s Degree in a STEM discipline with a minimum of 8 years of related experience
- Bachelor’s Degree in a STEM discipline with a minimum of 10 years of related experience
- Associate’s Degree in a STEM discipline with a minimum of 14 years of related experience
Benefits
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
Medical, dental, and vision benefits effective day one of employment
Tuition reimbursement
Why you should join Catalent
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 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.