QA Specialist I — Supplier & Material Quality

Catalent; Madison (WI); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health, dental and vision benefits

Tuition Reimbursement

401K match

PTO and holidays

Job summary

Catalent Biologics is hiring for a Specialist I, Quality Assurance in Madison, WI. This on-site role supports supplier and material QA programs, audits, and regulatory compliance within a fast-growing, global drug development leader.

The Candidate will ensure supplier quality, manage audits, and collaborate across Catalent sites to maintain quality agreements, with a strong emphasis on CGMP and regulatory adherence.

Qualifications

• Doctorate or Master’s/Bachelor’s/Associate in STEM with related experience requirements as listed.
• Proficiency with Excel, Word, and office systems.
• Experience with quality management software such as TrackWise® or ComplianceWire®.
• Ability to apply CGMPs to daily work and maintain data integrity.
• Strong understanding of regulatory expectations (FDA, ICH, GMP).
• Advanced knowledge of pharmaceutical lab and production operations.

Responsibilities

• Ensure compliance and effectiveness of Supplier and Material QA programs.
• Maintain and audit the Approved Supplier List.
• Plan and conduct supplier/vendor audits per site policies.
• Evaluate audit results and follow up on corrective actions.
• Collaborate with sister Catalent sites and suppliers to draft Quality Agreements.
• Support supplier/material quality controls and training initiatives.
• Maintain controlled documents and support CGMP regulatory needs.
• Perform other duties as assigned.

Skills

Excel

Office software

CGMPs knowledge

Data integrity

Auditing

Attention to detail

Education

Doctorate Degree in STEM

Master’s Degree in STEM

Bachelor’s Degree in STEM

Associates Degree in STEM

Tools

TrackWise

ComplianceWire

Job description

Catalent Biologics is hiring for a Specialist I, Quality Assurance in Madison, WI. This on-site role supports supplier and material QA programs, audits, and regulatory compliance within a fast-growing, global drug development leader.

The Candidate will ensure supplier quality, manage audits, and collaborate across Catalent sites to maintain quality agreements, with a strong emphasis on CGMP and regulatory adherence.