Senior Associate - Quality Assurance Systems, SQM

Senior Associate I
- Quality Assurance Systems, SQM

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.

Catalent Pharma Solutions in Madison, WI is hiring a Senior Associate I
- Quality Assurance Systems, SQM.

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.

• Accountable for the incoming material inspection and disposition process.
• Collaborates with Quality Control, Materials Management and Manufacturing to ensure that suitable materials are available for use.
• Manage processing defective materials, including disposition and identification of corrective action as necessary. Provides support for the introduction of new materials.
• Creates, revises, and maintains material specifications.
• Support management and assessment of supplier notifications and material change requirements.
• Maintains the records pertaining the material lifecycle and lot disposition.
• Assists in the customer and supplier auditing process providing administrative support including information gathering and organization.
• Other duties as assigned.

• 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.

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