QA Systems Specialist III – CAPA & Investigations

Catalent; Madison (WI); In loco; USD 90.000 - 130.000; Tempo pieno

Vantaggi offerti da questo lavoro

Career development

Diverse culture

Career growth

Paid time off

Community initiatives

Benefits from day one

Tuition reimbursement

Descrizione del lavoro

Catalent is seeking a Specialist III – Quality Assurance, Systems for our Madison, WI site. You will manage deviations, CAPA investigations, and support Out‑of‑Specification investigations to ensure compliant quality systems and operational excellence.

The role involves technical support, training, document control, client communications, and continual process improvements in a 100% on‑site environment. Doctorate with 6+ years or higher STEM degrees with related experience are required.

Competenze

• Doctorate or Master’s with related experience in STEM.
• Experience with quality systems, CAPA, deviations, investigations.
• Strong documentation control and client communication skills.

Mansioni

• Quality review and approval of deviations, investigations, and complaints.
• Oversee CAPAs opened for deviations and investigations.
• Address client comments on investigations and participate in client calls.
• Provide technical assistance and training for personnel on QA systems.
• File and maintain controlled documents and ensure compliance with GMP.
• Contribute to process improvements and metrics reporting.

Conoscenze

Quality Assurance

CAPA management

Deviations handling

Client communication

Documentation control

Training & mentoring

Formazione

Doctorate in STEM

Master’s in STEM

Bachelor’s in STEM

Associate’s in STEM

Strumenti

QMS software

Descrizione del lavoro

Catalent is seeking a Specialist III – Quality Assurance, Systems for our Madison, WI site. You will manage deviations, CAPA investigations, and support Out‑of‑Specification investigations to ensure compliant quality systems and operational excellence.

The role involves technical support, training, document control, client communications, and continual process improvements in a 100% on‑site environment. Doctorate with 6+ years or higher STEM degrees with related experience are required.