Senior Clinical Laboratory Auditor
Abbott · Abbott Park, IL
QualityFull-time$113k–$227kCompany career page
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Role summary
Abbott seeks a Senior Clinical Laboratory Auditor to lead quality system audits across clinical laboratory and manufacturing sites. The role ensures compliance with global regulatory standards and GCP requirements, with responsibility for audit strategy, risk assessment, and executive reporting.
What they're looking for
- Bachelor's degree or equivalent experience in scientific field
- Lead auditor certificate for quality system audits
- Demonstrated expertise auditing clinical laboratories and research/testing facilities
- Thorough knowledge of GCP, CLIA, CAP, ISO 17025, ISO 14155, ISO 15189, 21 CFR Part 820/QMSR, ISO 13485, EU MDR
- Ability to work independently and exercise judgment on complex compliance issues
- Strong communication and decision-making skills across management levels
What you'll be doing
- Direct, plan, and implement audit policies and programs division-wide
- Lead risk-based quality system audits at Abbott clinical laboratory and manufacturing sites
- Evaluate compliance with global regulations and standards including GCP requirements
- Monitor emerging regulatory requirements and industry trends to develop audit strategies
- Write professional audit reports and communicate risks to executive management
Privacy & handoff
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