Specialist II - Quality Assurance Operations, Compliance

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.

The Quality Assurance department is responsible for all aspects of the quality assurance functions at Catalent, Madison. The department’s primary function is to ensure compliance with FDA and other regulatory agency requirements as well as internal quality systems requirements. This includes systems implementation and maintenance, documentation management, site-wide systems training, internal and external auditing, project review actions to ensure regulatory compliance, which is essential in providing high quality drug products for our clients and their patients.

• 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.

• 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.

• 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! 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.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If…