Senior QA Supplier Compliance Specialist

Fresenius Kabi USA; Leyden Township (IL); Vor Ort; USD 98.000 - 113.000; Vollzeit

Benefits dieser Stelle

Bonus plan (target 6% of base)

401(k) with company contributions

Paid vacation, holidays and personal.

Medical, dental and vision coverage

Life insurance and wellness program

Zusammenfassung

Fresenius Kabi USA is seeking a Sr QA Supplier Specialist to support regulatory, ISO, and global compliance. You will oversee supplier management, audits, and quality agreements across US and global suppliers, ensuring adherence to GMP and quality systems. The role has no supervisory duties and offers bonus potential and comprehensive benefits.

The position requires a B.S. in sciences with 5+ years of QA/QC in pharma, strong communication, and the ability to work independently in a regulated

Qualifikationen

• Bachelor's degree in sciences with 5+ years of QA/QC experience in pharmaceutical or related regulated industry.
• Deep knowledge of current GMP and related quality systems.
• Strong communication, interpersonal, negotiation, and problem-solving skills.
• Organized, detail-oriented, able to manage multiple tasks and work independently.
• English is the primary business language; ability to read/write/understand English is essential.

Aufgaben

• Facilitates supplier management activities and qualification of new/existing suppliers.
• Collaborates with cross-functional teams for supplier (re)qualification activities.
• Interfaces with suppliers for audits (on-site, virtual, hybrid, or document) and requests documentation.
• Performs supplier (re)qualification audits and reviews documentation.
• Maintains regional and global supplier tracking databases.
• Supports internal, regional, and global departments with supplier inquiries.
• Manages and maintains Approved Vendor List and quality agreements.
• Participates in regional internal audits as Lead or Co-auditor and drafts audit reports.
• Updates internal audit tracking databases and CAPA plans; ensures timely closures.

Kenntnisse

Supplier management

Internal audits

Quality systems

GMP knowledge

Documentation control

Ausbildung

Bachelor's degree in sciences

Jobbeschreibung

Fresenius Kabi USA is seeking a Sr QA Supplier Specialist to support regulatory, ISO, and global compliance. You will oversee supplier management, audits, and quality agreements across US and global suppliers, ensuring adherence to GMP and quality systems. The role has no supervisory duties and offers bonus potential and comprehensive benefits.

The position requires a B.S. in sciences with 5+ years of QA/QC in pharma, strong communication, and the ability to work independently in a regulated