Senior QA Supplier Specialist - Compliance & Audits

Fresenius Kabi USA; Melrose Park (IL); On-site; USD 98,000 - 113,000; Full time

Job summary

Fresenius Kabi USA is seeking a Sr QA Supplier Specialist in Melrose Park, IL to advance supplier qualification and audit programs. You will partner with cross-functional teams to ensure GMP compliance and maintain the Approved Vendor List, while guiding supplier quality activities and documentation.

The role involves leading or supporting internal audits, maintaining quality agreements, and preparing reports for regulatory and management reviews.

Qualifications

• Bachelor's degree in the sciences with 5+ years QA/QC in pharma or related regulated industry.
• Strong knowledge of current GMP and related quality systems.
• Excellent communication, negotiation and problem-resolution skills.
• Organized, detail-oriented and able to multitask with minimal supervision.

Responsibilities

• Facilitates supplier management program activities and qualification of suppliers.
• Conducts supplier audits (on-site, virtual, or document) and prepares audit reports.
• Maintains Approved Vendor List and supplier tracking databases.
• Supports internal audits as Lead or Co-auditor and drafts audit reports and CAPA plans.
• Develops and maintains quality agreements with suppliers and internal stakeholders.
• Assists with regulatory inspections and prepares monthly supplier data for APQR as needed.

Skills

Supplier management

Audit coordination

Communication

Problem solving

Documentation

Education

Bachelor's degree in the sciences

Tools

QA systems

Supplier tracking databases

Internal audit databases

Quality agreements databases

Job description

Fresenius Kabi USA is seeking a Sr QA Supplier Specialist in Melrose Park, IL to advance supplier qualification and audit programs. You will partner with cross-functional teams to ensure GMP compliance and maintain the Approved Vendor List, while guiding supplier quality activities and documentation.

The role involves leading or supporting internal audits, maintaining quality agreements, and preparing reports for regulatory and management reviews.