Senior Clinical Lab Auditor—Compliance Leader

Abbott; Chicago (IL); On-site; USD 113,000 - 227,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Tuition reimbursement

Education benefits

Recognition program

Job summary

Abbott Park, IL, is seeking a Senior Clinical Laboratory Auditor to lead risk-based Quality System audits across Abbott Clinical Laboratory and manufacturing sites. The role ensures compliance with GCP, CLIA, CAP and ISO standards, and reports to executive management.

You will develop audit programs, review risk and validation documents, and drive continuous improvement across divisions while coordinating with corporate teams. Abbott offers extensive health and retirement benefits.

Qualifications

• Bachelor’s Degree or equivalent in a scientific field.
• Lead auditor certificate for Quality System audits.
• Thorough knowledge of Good Clinical Practice (GCP).
• Independent thinking and planning ability.
• 7+ years’ experience in clinical research, QA, or medical/scientific area.

Responsibilities

• Direct, plan, develop and implement audit policies and programs.
• Lead in-depth risk-based Quality System audits at sites.
• Plan, execute, and report site audits with corrective actions.
• Evaluate compliance with GLP/GCP standards and ISO/regulations.
• Write audit reports for executive management with risk context.
• Develop audit training and competency assessments.

Skills

Lead auditor certificate

GCP knowledge

Independent thinking

Communication skills

Auditing experience

Education

Bachelor's Degree in a scientific field

Tools

Audit software

Job description

Abbott Park, IL, is seeking a Senior Clinical Laboratory Auditor to lead risk-based Quality System audits across Abbott Clinical Laboratory and manufacturing sites. The role ensures compliance with GCP, CLIA, CAP and ISO standards, and reports to executive management.

You will develop audit programs, review risk and validation documents, and drive continuous improvement across divisions while coordinating with corporate teams. Abbott offers extensive health and retirement benefits.