Senior Specialist I - Quality Assurance Operations, On the Floor

About the role

Work Schedule: M-F 8am-5pm, 100% on-site. Catalent Biologics is making significant investments in people and capabilities, offering a unique opportunity 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 designed to treat various diseases.

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

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

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