Senior QA & Supplier Compliance Specialist

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

Benefits offered by this job

Bonus plan: 6% target of base salary

401(k) with company contributions

Paid vacation, holidays and personal/P

Health benefits: medical, prescription

Dental and vision coverage

Employee assistance program

Wellness program

Job summary

Fresenius Kabi USA, LLC seeks a Sr QA Supplier Specialist to support regulatory, ISO and global compliance across supplier management and internal audit activities. This role involves audits (on-site, virtual, hybrid or document), supplier qualification, and maintaining supplier databases to ensure quality across the network.

The position offers a bonus plan with a target of 6% of base salary and a comprehensive benefits package including a 401(k) with company contributions, paid time off, and

Qualifications

• Bachelor's degree in the sciences with 5+ years of QA/QC in pharmaceutical or regulated industry.
• Solid knowledge of current GMP and related quality systems.
• Strong communication, interpersonal, negotiation and problem resolution skills.
• Highly organized, detail oriented and able to handle multiple tasks.
• Ability to function independently with minimal supervision.

Responsibilities

• Facilitates supplier management activities and qualification of new and existing suppliers.
• Collaborates with cross-functional groups to complete supplier (re)qualification.
• Interfaces with suppliers for audits and requests (re)qualification docs.
• Performs supplier (re)qualification audits and reviews documentation.
• Prepares supplier (re)qualification reports and evaluations.
• Maintains regional and global supplier tracking databases.
• Supports internal, local, regional, and global departments on supplier questions.
• Manages and maintains Approved Vendor List.
• Supports regional internal audit program and audit scheduling.
• Participates as Lead or Co-auditor in internal audits.
• Plans and conducts internal audits and drafts audit reports.
• Coordinates quality agreements with suppliers and internal entities.
• Maintains regional and global Quality Agreement databases.
• Assists in monthly management reviews and APQR data preparation.
• Supports inspections and quality programs related to suppliers.

Skills

QA/QC knowledge

GMP knowledge

Communication skills

Organizational skills

Independent worker

Education

Bachelor's degree in the sciences

Job description

Fresenius Kabi USA, LLC seeks a Sr QA Supplier Specialist to support regulatory, ISO and global compliance across supplier management and internal audit activities. This role involves audits (on-site, virtual, hybrid or document), supplier qualification, and maintaining supplier databases to ensure quality across the network.

The position offers a bonus plan with a target of 6% of base salary and a comprehensive benefits package including a 401(k) with company contributions, paid time off, and