Specialist - Quality Assurance Operations, Data Review

Specialist I, Quality Assurance, Data Review

Position Summary:

Work Schedule:

Monday – Friday, 8:00 am – 5:00 pm; 100% on-site.

Location:

Catalent Pharma Solutions, Madison, WI.

• Maintain and enhance the effectiveness of the Quality System through compliant preparation and execution of quality control operations.
• Review analytical and microbiology data and documentation for accuracy, completeness, and compliance.
• Report unusual or out‑of‑specification testing results.
• Verify laboratory records and associated documents for traceability, ensuring reagents, standards, and equipment are within acceptance ranges.
• Ensure analysts follow all applicable SOPs and CGMP regulations, work with analysts for document corrections, and provide guidance.
• Interface with clients and manage internal communication to sustain and enhance client–quality relationships.
• Review and approve quality‑control related deviation investigation records.
• Provide consultation and guidance for Quality Control personnel regarding execution of the Quality Management Systems.
• Notify Management of potential quality or regulatory issues affecting product quality or compliance.
• Other duties as assigned.

• Doctorate in a STEM discipline with minimum of 0 years related experience.
• Master’s Degree in a STEM discipline with minimum of 4 years related experience.
• Bachelor’s Degree in a STEM discipline with minimum of 6 years related experience.
• Associate’s Degree in a STEM discipline with minimum of 10 years related experience.
• Proficiency with Excel, Word, and other office systems.
• Prior work experience with quality management software such as Track Wise® or Compliance Wire®.

• Defined career path with annual performance reviews and feedback.
• Diverse, inclusive culture.
• Positive working environment focused on continuous improvement and innovation.
• Opportunity for career growth on an expanding team.
• 152 hours of PTO plus 8 paid holidays.
• Generous 401(k) match.
• Medical, dental, and vision benefits effective day one of employment.
• Tuition reimbursement.

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 sending an email to Disabili