Senior QA Systems Specialist - CAPA & Investigations

Catalent, Inc.; Madison (WI); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

Tuition reimbursement

Paid time off and 8 holidays

Job summary

Catalent, Inc. is seeking a Specialist III – Quality Assurance, Systems at its Madison, Wisconsin facility. The role focuses on managing investigations, CAPA processes, and quality system improvements on-site to ensure compliance and operational excellence.

It involves detailed reviews, cross-functional collaboration, and training support. Ideal candidates hold a STEM degree with extensive related experience and are prepared for a 100% on-site schedule.

Qualifications

• Doctorate Degree in a STEM discipline with a minimum of 6 years of related experience.
• Master’s Degree in a STEM discipline with a minimum of 8 years of related experience.
• Bachelor’s Degree in a STEM discipline with a minimum of 10 years of related experience.
• Associate’s Degree in a STEM discipline with a minimum of 14 years of related experience.

Responsibilities

• Perform quality review and approval on deviations, laboratory investigations, and complaints
• Oversee Corrective and Preventive Actions (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

CAPA

Deviations handling

Client communications

Education

Doctorate Degree in STEM

Master’s Degree in STEM

Bachelor’s Degree in STEM

Associate’s Degree in STEM

Job description

Catalent, Inc. is seeking a Specialist III – Quality Assurance, Systems at its Madison, Wisconsin facility. The role focuses on managing investigations, CAPA processes, and quality system improvements on-site to ensure compliance and operational excellence.

It involves detailed reviews, cross-functional collaboration, and training support. Ideal candidates hold a STEM degree with extensive related experience and are prepared for a 100% on-site schedule.