Senior Clinical Lab Quality Auditor

Thornton Tomasetti; United States; Presencial; USD 113.000 - 227.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Free HIP PPO medical plan (next year)

High employer retirement contribution

Tuition reimbursement

Descripción de la vacante

Abbott Park, IL is seeking a Lead Auditor to direct risk-based quality system audits across clinical and manufacturing sites. You will plan, execute, and report audits, ensuring adherence to CLIA, CAP, ISO and EU MDR standards.

The role requires strong analytical skills, independent thinking, and the ability to communicate risks to executive management. The position offers opportunities to develop audit programs, train auditors, and influence regulatory compliance across Abbott’s global

Formación

• Bachelor’s Degree or equivalent experience in a scientific field
• Lead auditor certificate for Quality System audits
• Thorough knowledge and application of Good Clinical Practice (GCP) including CLIA, CAP, ISO 17025, ISO 14155, ISO 15189, ISO 17025, 21 CFR Part 820/QMSR, ISO 13485 and EU MDR
• Independent thinking and planning ability
• Strong analytical and problem-solving skills with attention to detail
• Highly effective oral and written communication, critical thinking, and decision-making skills
• Ability to manage multiple audits and prioritize effectively
• Proficiency in audit tools; ISO Lead Auditor certifications desirable
• Experience supporting clinical research, QA or related medical/scientific work
• Experience conducting risk-based audits of vendors and clinical sites

Responsabilidades

• Lead audits of Quality Systems across Abbott Clinical Laboratory and manufacturing sites
• Plan, execute, and report audits including evaluation of corrective actions
• Develop risk-based audit programs and training for auditors
• Evaluate compliance with global GCP standards and regulations
• Monitor evolving regulatory requirements and industry trends to shape audit strategy
• Prepare executive-level audit reports and communicate risks to management
• Review documentation and validation protocols for completeness and compliance
• Identify non-conformities and areas for improvement

Conocimientos

Lead auditor certificate

GCP knowledge

Audit planning

Regulatory inspections

Quality systems auditing

Risk assessment

Analytical skills

Communication skills

Time management

Independent thinking

Educación

Bachelor’s Degree in a scientific field

Descripción del empleo

Abbott Park, IL is seeking a Lead Auditor to direct risk-based quality system audits across clinical and manufacturing sites. You will plan, execute, and report audits, ensuring adherence to CLIA, CAP, ISO and EU MDR standards.

The role requires strong analytical skills, independent thinking, and the ability to communicate risks to executive management. The position offers opportunities to develop audit programs, train auditors, and influence regulatory compliance across Abbott’s global