Senior QA & Supplier Compliance Expert

Fresenius; Melrose Park (IL); Hybrid; USD 98,000 - 113,000; Full time

Job summary

Fresenius Kabi in the United States seeks a Sr QA Supplier Specialist to support regulatory, ISO and global compliance. You will manage supplier qualification, audits, and quality agreements across regional and global scopes.

The role emphasizes cross-functional collaboration and maintaining approved vendor lists, with a compensation package including 401(k) contributions and comprehensive benefits. English proficiency and independent work are essential.

Qualifications

• Bachelor’s degree in the sciences with 5+ years QA/QC in pharma or regulated industry.
• Deep knowledge of GMP and related quality systems.
• Strong communication, interpersonal, negotiation and problem-resolution skills.

Responsibilities

• Facilitates supplier management program and qualification of suppliers.
• Conducts supplier audits (on-site, virtual, hybrid, or document).
• Prepares supplier qualification reports and CAPA reviews.
• Manages and maintains Approved Vendor List and Quality Agreements.
• Supports internal, regional, and global audits and inspections.
• Prepares monthly supplier data for APQR and supports management reviews.

Skills

Communication

Interpersonal skills

Negotiation

Problem solving

Education

Bachelor's degree in the sciences

Job description

Fresenius Kabi in the United States seeks a Sr QA Supplier Specialist to support regulatory, ISO and global compliance. You will manage supplier qualification, audits, and quality agreements across regional and global scopes.

The role emphasizes cross-functional collaboration and maintaining approved vendor lists, with a compensation package including 401(k) contributions and comprehensive benefits. English proficiency and independent work are essential.