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Senior Associate - Quality Assurance
Job in
Madison, Dane County, Wisconsin, 53774, USA
Listed on 2026-07-14
Listing for:
Catalent
Full Time
position Listed on 2026-07-14
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, Quality Control - QC Analysts/Managers, QA Specialist - Analyst/Manager, Production QC/QA
Job Description & How to Apply Below
Senior Associate I - Quality Assurance Operations, Data Review
Position Summary:
- Work Schedule:
Monday – Friday 8am-5pm - 100% on-site
Catalent Madison is a pharmaceutical manufacturing site specializing in the development and production of high-quality drug products, with a strong focus on biologics and sterile injectables. The site supports global clients by delivering compliant, reliable, and scalable manufacturing solutions.
Role- 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.
- Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
- Other duties as assigned.
- Master’s degree in STEM discipline with minimum of 0 years related experience.
- OR
- Bachelor's Degree in STEM discipline with minimum of 3 years related experience.
- OR
- Associate’s Degree in STEM discipline with minimum of 6 years related experience.
- OR
- High School Diploma with a minimum of 7 years related experience.
- Potential for career growth on an expanding team
- Abundance of cross‑functional exposure to other areas within the organization
- Opportunity to work globally
- 152 hours of paid time off annually + 8 paid holidays
- Day‑one benefits! Medical, dental, vision and 401K benefits effective on your first day
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, please contact Disabili
. This option is reserved for individuals who require accommodation due to a disability.
Position Requirements
10+ Years
work experience
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