Senior Specialist - Quality Assurance Operations, Floor

Senior Specialist I – Quality Assurance

Position Summary:

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 a Senior Specialist I – Quality Assurance. 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.

The Role:

• Ensures compliant manufacturing execution.
• Participates in deviations, CAPA, and change control investigations.
• Oversees Cell Bank inventory.
• Reviews and approves production and technical documents.
• Supports QA-on-the-floor and CGMP documentation review.
• Leads continuous improvement initiatives.
• Notifies management of quality or regulatory risks.
• Performs additional duties to maintain compliance.
• Other duties as assigned.

The Candidate:

• PhD in STEM discipline with 7+ years of related experience, OR
• Master's in STEM discipline with 10+ years of related experience, OR
• Bachelor's in STEM discipline with 15+ years of related experience, OR
• Associate's in STEM discipline with 17+ years of related experience
• Strong knowledge of: cGMP, FDA, EMA, ICH guidelines
• Experience with:
  Track Wise®, Compliance Wire®
• Capabilities:
  Investigations, deviations, CAPA, Risk assessments (FMEA, FTA, etc.), Data analysis and trend interpretation

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! 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.