Senior QA Systems Specialist — CAPA & Investigations

Catalent Pharma Solutions; Kentucky; Sur place; USD 90 000 - 120 000; Plein temps

Avantages offerts par ce poste

Career growth

Diversity & inclusion

PTO & holidays

Tuition reimbursement

Résumé du poste

Catalent Pharma Solutions is seeking a Specialist III – Quality Assurance, Systems to join our Madison, WI site. The role focuses on investigation and CAPA management, handling high-level deviations, and ensuring quality system improvements for compliance and operational excellence.

The position involves providing technical assistance, training, and maintaining controlled documents while collaborating with internal stakeholders and clients to drive timely resolution and continuous improvement.

Qualifications

• Doctorate, Master, Bachelor or Associate in a STEM discipline with related experience.
• Experience in quality assurance systems, deviations, CAPA, investigations.
• Ability to manage controlled documents and provide technical training.

Responsabilités

• 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

Connaissances

Quality Assurance

CAPA management

Investigations

GxP

Documentation

Formation

Doctorate in STEM

Master in STEM

Bachelor in STEM

Associate in STEM

Description du poste

Catalent Pharma Solutions is seeking a Specialist III – Quality Assurance, Systems to join our Madison, WI site. The role focuses on investigation and CAPA management, handling high-level deviations, and ensuring quality system improvements for compliance and operational excellence.

The position involves providing technical assistance, training, and maintaining controlled documents while collaborating with internal stakeholders and clients to drive timely resolution and continuous improvement.