Senior Associate I - Quality Assurance

Catalent Pharma Solutions • Madison, WI

7d • Onsite

About The Position

The Senior Associate I– Quality Assurance Operation, Data Review at Catalent Madison supports Quality Assurance across a broad range of functions to ensure compliance with FDA regulations and internal quality systems, directly contributing to the production of safe, high-quality biologic drug products. This position spans equipment management, document control, materials quality, training, investigations/CAPA, audits, and on-the-floor manufacturing support. The Senior Associate I– Quality Assurance Operations, Data Review requires close cross-functional collaboration to maintain inspection readiness, drive continuous improvement, and support end-to-end quality oversight from raw materials through final product release.

Requirements

• 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.

Responsibilities

• Responsible for maintaining and enhancing the effectiveness of the Quality System through ensuring compliant preparation and execution of quality control operations.
• Review analytical and microbiology data and documentation including raw data, test methods, protocols, and reports for accuracy, completeness, and compliance in a timely manner.
• Review and report unusual or out-of-specification testing results
• Review supporting documentation including laboratory records and associated documents to ensure traceability to raw data and verify all reagents, standards and equipment used are within the acceptance range.
• Ensure analysts follow all applicable SOPs and CGMP regulations and work with analysts for document corrections and provide guidance accordingly.
• Notifies Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
• Other duties as assigned.

Benefits

• Medical
• dental
• vision
• 401K benefits
• 152 hours of paid time off annually
• 8 paid holidays

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED