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, supplier management, and quality assurance within the pharmaceutical industry. Proficient in conducting audits, maintaining quality systems, and preparing detailed reports to support compliance and operational excellence.

Highest-signal resume keywords

Regulatory ComplianceSupplier ManagementQuality AssuranceGMP KnowledgeAudit Facilitation

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Supplier QualificationAudit ReportingCAPA ReviewQuality Agreement ManagementDatabase MaintenanceData AnalysisRegulatory Inspection SupportInternal Audit ExecutionSupplier TrackingQuality System Implementation

Soft Skills

Communication SkillsInterpersonal SkillsNegotiation SkillsProblem ResolutionOrganizational Skills

Industry Keywords

Pharmaceutical IndustryGMPISO ComplianceQuality SystemsRegulated IndustrySupplier AuditsInternal AuditsQuality AgreementsVendor ManagementProgressive QA/QC Experience

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 qualification of new and existing suppliers
Collaborate with cross-functional groups on supplier requalification activities
Interface with suppliers for audits and qualification documentation
Perform supplier requalification audits and review related documentation
Prepare supplier qualification and assessment reports
Maintain regional and global supplier tracking databases
Support supplier qualification activities and supplier-related requests
Manage and maintain the Approved Vendor List
Facilitate the regional internal audit program
Schedule, conduct, and close internal audits as Lead or Co-auditor
Draft audit reports, review CAPA plans, and issue audit closures
Maintain the internal audit tracking database
Execute and 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
Prepare monthly supplier data for product APQR
Support internal, external, customer, and regulatory inspections
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 the 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; 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