Senior Associate I - Quality Assurance Operations

About the role

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 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.

Responsibilities

• Accountable for execution of the QA on the Floor program.
• Performs routine walkthroughs of the Manufacturing Area partnering with manufacturing on Quality best practice implementation and troubleshooting when problems arise.
• Provides direct quality support for routine manufacturing operations.
• Responsible issuance of controlled documents for production, including Batch Production Records, Product Labels and forms.
• Responsible for review of documentation, including batch records, test data, environmental monitoring data, and logbooks, for production of solutions and columns used in the manufacture of bulk drug substance.
• Performs release of produced solutions and columns.
• Assists with inspection of final product containers
• Supports shipment of finished products.
• Responsible for review of facility and equipment records in support of GMP operations.
• Accountable for control and management of Cell Bank inventory
• Notifies Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
• Files and maintains controlled documents.
• Other duties as assigned.

Qualifications

• Master’s degree in STEM discipline with minimum of 0 years related experience.
• Bachelor's Degree in STEM discipline with minimum of 3 years related experience.
• Associates Degree in STEM discipline with minimum of 6 years related experience.
• High School Diploma with a minimum of 7 years related experience.

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

Schedule

Work Schedule: Mon-Fri 8am-5pm, 100% on-site