Senior QA Supplier & Compliance Specialist

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

Job summary

Fresenius Kabi USA in Melrose Park, IL seeks a Sr QA Supplier Specialist to support regulatory, ISO and global compliance while ensuring supplier management and internal audits comply with established procedures.

Responsibilities include cross‑functional collaboration for supplier qualifications, maintaining supplier databases and the Approved Vendor List, and supporting regional and global quality agreements. Strong QA/QC background and English proficiency are required.

Qualifications

• Bachelor's degree in the sciences plus 5+ years QA/QC in pharma or related regulated industry.
• Deep knowledge of GMP and quality systems.
• Strong communication and interpersonal skills with negotiation and problem solving abilities.
• Organized, detail oriented, able to manage multiple tasks.
• Independent work style with minimal supervision.
• Business language is English; ability to read/write/understand policies and training materials in English.

Responsibilities

• Facilitate supplier management activities and qualification of new/existing suppliers.
• Collaborate with cross-functional teams to complete supplier requalification tasks.
• Interface with suppliers for audits (on-site, virtual, hybrid, or document) and collect qualification documents.
• Prepare supplier qualification or evaluation reports.
• Update regional and global supplier tracking databases.
• Assist team members with supplier qualification activities as needed.
• Support local, regional, and global departments with supplier inquiries.
• Manage and maintain the Approved Vendor List.
• Support Regional internal audit programs and ensure audits are scheduled, conducted, and closed.
• Lead or co-audit internal audits and draft reports, CAPA reviews, and closure.

Skills

GMP knowledge

Communication skills

Interpersonal skills

Negotiation

Problem solving

Independence

English proficiency

Multitasking

Attention to detail

Education

Bachelor's degree in the sciences

Job description

Fresenius Kabi USA in Melrose Park, IL seeks a Sr QA Supplier Specialist to support regulatory, ISO and global compliance while ensuring supplier management and internal audits comply with established procedures.

Responsibilities include cross‑functional collaboration for supplier qualifications, maintaining supplier databases and the Approved Vendor List, and supporting regional and global quality agreements. Strong QA/QC background and English proficiency are required.