Senior QA Supplier Specialist

Fresenius Kabi USA

. Support the company's short- and long-term goals for regulatory, ISO, and global compliance .

Posted 10/5/2026full-timeMelrose Park • Illinois • United StatesSenior💰 $98,000 - $113,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory compliance, quality assurance, and supplier management within the pharmaceutical industry, with a strong focus on GMP standards and internal audit processes.

Highest-signal resume keywords

Regulatory ComplianceQuality AssuranceSupplier ManagementGMP KnowledgeInternal Auditing

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality SystemsSupplier Requalification AuditsAudit Report PreparationQuality Agreement ManagementCAPA ReviewDatabase MaintenanceSupplier TrackingManagement Review PresentationsRegulatory Inspections SupportSupplier Qualification Documentation

Soft Skills

Strong CommunicationInterpersonal SkillsNegotiation SkillsProblem ResolutionOrganizational SkillsDetail-OrientedIndependent Functioning

Tools & Technologies

Supplier Tracking DatabasesInternal Audit Tracking DatabaseQuality Agreement Databases

Industry Keywords

Pharmaceutical IndustryISO ComplianceQuality AssuranceQuality ControlRegulated IndustrySupplier ManagementInternal AuditsGMP

About the role

Key responsibilities & impact

Support the company's short- and long-term goals for regulatory, ISO, and global compliance
Facilitate supplier management activities and support qualification of new and existing suppliers
Collaborate with cross-functional groups on supplier requalification activities
Interface with suppliers for on-site, virtual, hybrid, or document audits and request qualification documentation
Perform supplier requalification audits and review related documentation
Prepare supplier requalification and assessment/evaluation reports
Maintain regional and global supplier tracking databases
Support local, regional, and global departments with supplier-related questions and requests
Manage and maintain the Approved Vendor List
Facilitate the regional internal audit program, including scheduling, conducting, and closing audits
Participate in internal audits as Lead or Co-auditor and prepare audit reports, review CAPA plans, and issue audit closure
Maintain the internal audit tracking database
Execute or support supplier and inter-company quality agreements
Collaborate on drafting, reviewing, and finalizing quality agreements
Perform periodic reviews of quality agreements and execute resulting actions
Maintain regional and global Quality Agreement databases
Prepare monthly management review presentations and supplier data for product APQR
Support internal, external, customer, and regulatory inspections as needed
Support maintenance and process improvement of supplier management, internal audit, and quality agreement programs

Requirements

What you’ll need

Bachelor's degree in the sciences
5+ years of progressive challenging 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 resolution skills
Organized, detail-oriented, and able to handle multiple tasks and redirect focus based on company needs
Ability to function independently with minimal supervision
Ability to effectively speak, read, write, and understand English
Must be authorized to work for any employer in the United States; employment visa sponsorship is unavailable

Benefits

Comp & perks

Bonus plan with a target of 6% of base salary
401(k) plan with company contributions
Paid vacation, holiday, and personal days
Employee assistance program
Medical, prescription drug, dental, and vision coverage
Life insurance
Disability coverage
Wellness program