Senior Clinical Laboratory Compliance Auditor

Abbott (abbottcareers2 board); Illinois; On-site; USD 120,000 - 150,000; Full time

Job summary

Abbott Park, IL. Abbott Quality Regulatory (AQR) seeks a Senior Clinical Laboratory Auditor to conduct risk-based audits of Clinical Laboratories, including research and testing labs, ensuring patient safety and compliance with GCP, CLIA, CAP, ISO 17025, ISO 14155, ISO 15189, ISO 13485 and EU MDR.

You will lead cross-divisional audits, assess regulatory trends, and prepare executive-level reports while maintaining independence and applying sound judgment in complex issues.

Qualifications

• Experience conducting risk-based audits of clinical laboratories.
• Knowledge of CLIA, CAP, ISO 17025, ISO 14155, ISO 15189, ISO 13485 and EU MDR.
• Ability to communicate audit findings to executive management.

Responsibilities

• Direct, plan, develop and implement audit policies and programs for systems division-wide.
• Lead in-depth quality system audits across Abbott Clinical Laboratory and manufacturing sites.
• Plan, execute and report site audits, evaluating corrective actions for effectiveness.
• Evaluate compliance with Good Clinical Practice standards and regulations.
• Monitor regulatory trends to shape audit strategies and identify focus areas.
• Maintain up-to-date knowledge of evolving regulations and best practices in regulatory compliance.
• Review documentation, risk files, and validation protocols for completeness and compliance.
• Identify non-conformities and areas for improvement; write audit reports for executives.

Skills

Auditing

Regulatory compliance

Risk assessment

Quality systems

Job description

Abbott Park, IL. Abbott Quality Regulatory (AQR) seeks a Senior Clinical Laboratory Auditor to conduct risk-based audits of Clinical Laboratories, including research and testing labs, ensuring patient safety and compliance with GCP, CLIA, CAP, ISO 17025, ISO 14155, ISO 15189, ISO 13485 and EU MDR.

You will lead cross-divisional audits, assess regulatory trends, and prepare executive-level reports while maintaining independence and applying sound judgment in complex issues.