Specialist - Quality Assurance Operations, Compliance

Specialist I - Quality Assurance Operations, Compliance Position Summary

Work Schedule:

M-F 8am-5pm; 100% on-site.

Working for Catalent Biologics offers the chance to join an entrepreneurial team focused on improving patient outcomes by developing products for COVID‑19, cancer, autoimmune, fibrotic, blood disorders, HIV, diabetes, heart and lung diseases, and Alzheimer’s.

Catalent Pharma Solutions in Madison, WI is a global drug development leader that supports biotech and pharma companies from early development to market.

• Executes internal audits, coordinating with subject matter experts, performing assessments of systems and procedures, and communicating audit findings.
• Supports customer audits, coordinating with customers and internal stakeholders, hosting audits, and following up on audit responses.
• Maintains facility licenses and registrations.
• Organizes documentation to support client regulatory submissions.
• Monitors regulatory guidance and compendial monographs.
• Supports and enhances effectiveness of the quality system, reporting metrics and authoring SOPs.
• Identifies improvement opportunities and assists with change control, risk management, and CAPA processes.
• Participates in cross‑functional teams to improve processes, systems, and address new regulations or expectations.
• Oversees customer Quality Agreements, facilitating development, approval and revision.
• Drafts and executes technical plans, protocols, control strategies, and reports related to process validation and monitoring.
• Maintains statistical tools for system and process monitoring.
• Provides oversight and decision‑making based on understanding of quality systems and operations.
• Files and maintains controlled documents.
• Other duties as assigned.

• Doctorate in STEM discipline with minimum 0 years related experience.
• Master’s in STEM discipline with minimum 4 years related experience.
• Bachelor’s in STEM discipline with minimum 6 years related experience.
• Associate’s in STEM discipline with minimum 10 years related experience.

• Defined career path and annual performance review.
• Diverse and inclusive culture.
• Positive working environment focused on continuous improvement.
• Career growth within an expanding organization.
• 152 hours of PTO plus 8 paid holidays.
• Generous 401(k) match.
• Medical, dental and vision benefits effective day one.
• Tuition reimbursement.

Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for the application or hiring process due to a disability, please email Disabili including the job number, title and location.