Quality Assurance Specialist I - Supplier & Audit Expert

Catalent; Madison (WI); Sur place; USD 60 000 - 80 000; Plein temps

Avantages offerts par ce poste

PTO + holidays

401K match

Benefits from day one

Tuition reimbursement

Résumé du poste

Catalent is hiring a Specialist I, Quality Assurance in Madison, WI. This on-site role supports supplier quality programs, audits, and regulatory compliance to ensure product quality for patients.

Candidates typically have STEM degrees and relevant QA experience with TrackWise/ComplianceWire, CGMPs, and data integrity. Join a global leader with strong career growth and comprehensive benefits.

Qualifications

• Doctorate Degree in STEM with 0+ years related experience.
• Master’s Degree in STEM with 4+ years related experience.
• Bachelor’s Degree in STEM with 6+ years related experience.
• Associates Degree in STEM with 10+ years related experience.
• Ability to use Excel, Word, and other office systems.
• Prior work experience with TrackWise or ComplianceWire.
• Ability to apply CGMPs to everyday work.
• Maintains data integrity and ensures compliance with SOPs, cGMP, FDA/ICH regulations.

Responsabilités

• Accountable for the compliance and effectiveness of the Supplier and Material Quality Assurance programs.
• Manages and maintains the Quality Approved Supplier List.
• Schedule and conduct audits of suppliers and vendors.
• Evaluate audit results and follow up on outstanding issues.
• Collaborate with Catalent sister sites and suppliers to draft Quality Agreements.
• Support the Supplier Quality Assurance team in corrective actions for material/supplier quality issues.

Connaissances

Audit management

TrackWise

ComplianceWire

cGMP

Excel

Formation

Doctorate Degree in STEM

Master’s Degree in STEM

Bachelor’s Degree in STEM

Associate Degree in STEM

Outils

Quality management software

Description du poste

Catalent is hiring a Specialist I, Quality Assurance in Madison, WI. This on-site role supports supplier quality programs, audits, and regulatory compliance to ensure product quality for patients.

Candidates typically have STEM degrees and relevant QA experience with TrackWise/ComplianceWire, CGMPs, and data integrity. Join a global leader with strong career growth and comprehensive benefits.