Senior Specialist I - Quality Assurance Operations, On the Floor

Catalent • Madison, WI

4d • Onsite

About The Position

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.

Requirements

• 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: TrackWise®, ComplianceWire®
• Capabilities: Investigations, deviations, CAPA, Risk assessments (FMEA, FTA, etc.), Data analysis and trend interpretation

Responsibilities

• 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 All other duties as assigned.

Benefits

• 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!

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Associate degree