QA Specialist III, Systems — CAPA & Investigations

Catalent; Madison (WI); On-site; USD 85,000 - 115,000; Full time

Benefits offered by this job

Paid time off

8 holidays

Health, dental, vision benefits

Tuition reimbursement

Job summary

Catalent’s Madison, Wisconsin site is a state‑of‑the‑art biologics development and manufacturing facility supporting customers from research through early‑ and mid‑stage clinical production.

This Specialist III – Quality Assurance, Systems role focuses on Investigation and CAPA Management Systems, handling high‑level deviations, and driving process improvements to sustain compliance and operational excellence.

Qualifications

• PhD in STEM with 6+ years related experience
• MS in STEM with 8+ years related experience
• BS in STEM with 10+ years related experience
• AS in STEM with 14+ years related experience

Responsibilities

• Perform quality review and approval on deviations, investigations, and complaints
• Oversee CAPAs opened in response to deviations
• Address client comments on investigations
• Participate in client calls to discuss investigation status
• Engage in customer contact as required
• Provide technical assistance and training for personnel
• File and maintain controlled documents
• All other duties as assigned.

Skills

Quality Assurance

Systems

CAPA

Investigations

Documentation

Education

Doctorate in STEM

Master’s in STEM

Bachelor’s in STEM

Associate’s in STEM

Job description

Catalent’s Madison, Wisconsin site is a state‑of‑the‑art biologics development and manufacturing facility supporting customers from research through early‑ and mid‑stage clinical production.

This Specialist III – Quality Assurance, Systems role focuses on Investigation and CAPA Management Systems, handling high‑level deviations, and driving process improvements to sustain compliance and operational excellence.