QA Systems Specialist III — CAPA & Investigations

Ourlivesmadison; Madison, Northern (WI, KY); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health benefits from day one

Paid holidays

Tuition reimbursement

Job summary

Catalent in Madison, Wisconsin seeks a Specialist III – Quality Assurance, Systems to lead investigations, manage CAPAs, and ensure robust quality systems on-site. The role involves client interactions, document control, and process improvements to sustain compliance and operational excellence.

The ideal candidate holds a STEM degree with extensive related experience and will advance quality systems, metrics, and training across the team at the Madison GMP facility.

Qualifications

• Doctorate degree in a STEM discipline with extensive related experience.
• Master’s degree in a STEM discipline with substantial related experience.
• Bachelor’s degree in a STEM discipline with significant related experience.
• Associate’s degree in a STEM discipline with many related years of experience.

Responsibilities

• 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.

Education

Doctorate Degree in a STEM discipline

Master’s Degree in a STEM discipline

Bachelor’s Degree in a STEM discipline

Associate’s Degree in a STEM discipline

Job description

Catalent in Madison, Wisconsin seeks a Specialist III – Quality Assurance, Systems to lead investigations, manage CAPAs, and ensure robust quality systems on-site. The role involves client interactions, document control, and process improvements to sustain compliance and operational excellence.

The ideal candidate holds a STEM degree with extensive related experience and will advance quality systems, metrics, and training across the team at the Madison GMP facility.