Specialist II - Quality Assurance Operations, Compliance
Position Summary
Work Schedule
M-F 8am-5pm
- 100% on-site
Working for Catalent Biologics is an opportunity to join an entrepreneurial team. Catalent Biologics is making significant investments in people and capabilities. This is a unique opening to join a small, fast-growing business, backed by a global public company. People joining our team will have the opportunity for career development as our business continues to grow and expand. Catalent-Madison employees are helping to improve future patient outcomes by working on products that are designed to treat COVID-19, cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart and lung diseases as well as Alzheimer's.
Catalent Pharma Solutions in Madison, WI is hiring Specialist II - Quality Assurance Operations, Compliance.
The Role
- Lead internal and customer audits, including coordination, execution, reporting, responses, and follow-up actions.
- Maintain regulatory compliance through facility licenses, registrations, documentation support, and monitoring of regulatory and compendial updates.
- Support and continuously improve Quality Management Systems (QMS), including SOPs, metrics, change control, risk management, CAPA, and process improvements.
- Manage quality agreements and provide quality oversight across systems, operations, and cross-functional improvement initiatives.
- Develop and execute validation and monitoring activities, including PPQ, CPV, APR/PQR reporting, statistical process monitoring, and controlled document management.
The Candidate
- Doctorate Degree in STEM discipline with minimum of 4 years related experience, OR
- Master's Degree in STEM discipline with minimum of 6 years related experience, OR
- Bachelor's Degree in STEM discipline with minimum of 8 years related experience, OR
- Associates Degree in STEM discipline with minimum of 12 years related experience.
Why you should join Catalent
- Defined career path and annual performance review and feedback process
- Diverse, inclusive culture
- Positive working environment focusing on continually improving processes to remain innovative
- Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
- 152 hours of PTO + 8 paid holidays
- Generous 401K match
- Medical, dental and vision benefits effective day one of employment
- Tuition Reimbursement - Let us help you finish your degree or start a new degree!
Catalent offers rewarding opportunities to further your career!
Volunteer Work Disclosure
Massachusetts Lie Detector Test Notice
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Who can apply
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