Senior Clinical Lab Quality Auditor - Regulatory Impact

Thornton Tomasetti; Illinois; On-site; USD 113,000 - 227,000; Full time

Job summary

Abbott Park, IL-based Senior Clinical Laboratory Auditor will lead risk-based audits of clinical laboratories and research/testing facilities to ensure patient safety and regulatory compliance. The role requires strong knowledge of GCP, CLIA, CAP, ISO 17025, ISO 14155, ISO 15189, ISO 13485 and EU MDR.

Responsibilities include planning audits, reporting findings, evaluating CAP/CLIA compliance, and guiding corrective actions while communicating risks to executive management.

Qualifications

• Bachelor's degree in a scientific field required.
• Lead auditor certification preferred.
• Thorough knowledge of GCP, CLIA, CAP, ISO standards and EU MDR is required.

Responsibilities

• Plan and lead risk-based audits of clinical laboratories and sites.
• Evaluate effectiveness of corrective actions and compliance with global standards.
• Identify non-conformities and communicate risks to senior management.
• Provide education on compliance and quality topics within Abbott.

Skills

Auditing

Regulatory compliance

Quality systems

Risk assessment

Communication

Education

Bachelor's degree in science

Tools

Audit software

Job description

Abbott Park, IL-based Senior Clinical Laboratory Auditor will lead risk-based audits of clinical laboratories and research/testing facilities to ensure patient safety and regulatory compliance. The role requires strong knowledge of GCP, CLIA, CAP, ISO 17025, ISO 14155, ISO 15189, ISO 13485 and EU MDR.

Responsibilities include planning audits, reporting findings, evaluating CAP/CLIA compliance, and guiding corrective actions while communicating risks to executive management.