Senior QA Systems Specialist – CAPA & Investigations

Catalent; Madison (WI); On-site; USD 105,000 - 140,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

8 paid holidays

Tuition reimbursement

Job summary

Catalent’s Madison, Wisconsin site seeks a Specialist III – Quality Assurance, Systems to manage investigations, CAPA processes, and quality systems improvements onsite in Madison. You will partner with internal stakeholders to ensure compliant execution and drive continuous improvement across QA programs.

The role emphasizes handling deviations, investigations, and client communications, with opportunities to contribute to company-wide quality initiatives.

Qualifications

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

Responsibilities

• Perform quality review and approval on deviations, laboratory 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

CAPA management

Investigations

Documentation

Client communication

Education

Doctorate in STEM

Master's in STEM

Bachelor's in STEM

Associate's in STEM

Tools

GMP systems

Document control

Job description

Catalent’s Madison, Wisconsin site seeks a Specialist III – Quality Assurance, Systems to manage investigations, CAPA processes, and quality systems improvements onsite in Madison. You will partner with internal stakeholders to ensure compliant execution and drive continuous improvement across QA programs.

The role emphasizes handling deviations, investigations, and client communications, with opportunities to contribute to company-wide quality initiatives.