Global Supplier Quality & Audit Specialist

Fresenius Kabi; Leyden Township (IL); In loco; USD 98.000 - 113.000; Tempo pieno

Vantaggi offerti da questo lavoro

401(k) with company contributions

Paid vacation and holidays

Employee assistance program

Health benefits: medical, Rx, dental,

Descrizione del lavoro

Fresenius Kabi in the United States is seeking a Sr QA Supplier Specialist to uphold regulatory, ISO, and global compliance. You will manage supplier qualification, audits, and quality agreements, supporting internal and external audits across US operations.

The role requires a Bachelor’s degree in sciences with 5+ years QA/QC experience in pharma and strong GMP knowledge. Excellent English communication and multitasking skills are essential.

Competenze

• Bachelor's degree in the sciences and 5+ years QA/QC experience in pharmaceutical or related regulated industry.
• In-depth knowledge of current GMP and related quality systems.
• Strong communication, interpersonal, negotiation, and problem-solving skills.
• Organized, detailed, and able to multitask with minimal supervision.
• English is the primary business language; able to read/write/understand technical materials in English.

Mansioni

• Facilitates activities in supplier management and supports qualification of new and existing suppliers.
• Collaborates with cross-functional groups to complete supplier qualification activities.
• Interfaces with suppliers for audits and requests (re)qualification documentation.
• Performs supplier (re)qualification audits and reviews documentation.
• Updates supplier tracking databases and prepares reports.
• Supports internal audit programs and assists with CAPA reviews and audit closures.
• Maintains quality agreements and supports regulatory inspections as needed.

Conoscenze

GMP knowledge

QA/QC experience

Communication skills

Organizational skills

Independent working

English proficiency

Formazione

Bachelor's degree in the sciences

Descrizione del lavoro

Fresenius Kabi in the United States is seeking a Sr QA Supplier Specialist to uphold regulatory, ISO, and global compliance. You will manage supplier qualification, audits, and quality agreements, supporting internal and external audits across US operations.

The role requires a Bachelor’s degree in sciences with 5+ years QA/QC experience in pharma and strong GMP knowledge. Excellent English communication and multitasking skills are essential.