Senior Associate - Quality Assurance Operations, Data Review

Senior Associate I – Quality Assurance Operations, Data Review

Location:

Madison, WI.

Work Schedule:

Monday – Friday, 8 AM – 5 PM. 100% on‑site.

• Maintain and enhance 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 a STEM discipline with a minimum of 0 years related experience.
• Bachelor’s degree in a STEM discipline with a minimum of 3 years related experience.
• Associate’s degree in a STEM discipline with a 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 401(k) 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. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by emailing Disabili and include the job number, title, and location. This request is reserved for individuals who require accommodation due to a disability and will be processed confidentially.