Senior Clinical Laboratory Auditor
Abbott
Summary
This position works out of our Abbott Park, IL location within the AQR Abbott Quality Regulatory division. The Abbott Quality and Regulatory (AQR) Global compliance audit function is a corporate program which conducts audits of Quality Systems across all of Abbott's Manufacturing and Clinical laboratory sites.
Job description
We are seeking an experienced Senior Clinical Laboratory Auditor with demonstrated expertise in auditing Clinical Laboratories, including research and testing laboratories, to ensure the protection of patient safety and compliance with applicable regulatory requirements, harmonised standards, and internal quality management system (QMS) procedures.
The role involves conducting risk-based audits across the full testing lifecycle, with a strong focus on quality system effectiveness, risk management activities, and adherence to global standards and regulations including application of Good Clinical Practice (GCP) including but not limited to CLIA, CAP, ISO 17025, ISO 14155, ISO 15189, ISO 17025, 21 CFR Part 820/QMSR, ISO 13485 and EU MDR.
What You'll Work On
- Work independently to direct, plan, develop and implement audit policies and programs for systems division-wide.
- Lead in-depth risk-based Quality System audits across all Abbott Clinical Laboratory and manufacturing sites.
- Plan, execute, and report Abbott Clinical Laboratory and manufacturing site audits, including evaluation of the effectiveness of corrective actions implemented.
- Evaluate compliance with global Good Clinical Practice standards and regulations including CLIA, CAP, ISO 17025, ISO 14155, ISO 15189, ISO 17025, 21 CFR Part 820/QMSR, ISO 13485 and EU MDR and other applicable regulations and standards.
- Monitor emerging regulatory requirements, industry trends and competitor analysis to develop audit strategies and identify products or process which require focused audits.
- Maintain up-to-date knowledge of evolving regulations and best practices in regulatory compliance.
- Review documentation, risk management files, and validation protocols for technical completeness and compliance.
- Identify non-conformities, product and process risks, and areas for improvement.
- Write professional audit reports for executive management.
- Communicate effectively to articulate risks and associated impact to all levels of management.
- Develop and provide professional education on compliance and quality topics that are key to Abbott businesses.
- Develop risk-based audit program including development of Abbott wide auditor training and competency assessments.
- Analyze compliance risks and communicate trends and opportunities to senior leadership and corporate policy makers.
- Promote and apply best-practice analysis and auditing tools, understanding their constraints, advantages, and disadvantages, and ensuring adherence to established standards.
- Promote continuous learning and improvement within the audit team.
Requirements
- Bachelor's Degree or equivalent experience in a scientific field of study
- Lead auditor certificate for Quality System audits
- Thorough knowledge and application of Good Clinical Practice (GCP) is required, i.e. 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 and techniques; certifications such as ISO Lead Auditor are desirable
- Effective time management skills
- Exceptional teamwork skills
- Requires a motivated, self-starter who can work independently once projects are assigned
- 7+ years' experience directly supporting clinical research, QA, or relevant experience in medical/scientific area
- Experience conducting risk-based audits of vendors, clinical testing and investigative sites
- Demonstrated experience working in clinical testing laboratories including: PCR and quantitative PCR, Next-generation sequencing (NGS), Gene expression analysis, DNA mutation analysis, ctDNA analysis, Bioinformatics interpretation, Immunohistochemistry
- Detailed knowledge of Clinical laboratory operations including: Sample receipt and accessioning, Molecular biology testing, Nucleic acid extraction, PCR/NGS processes, Bioinformatics analysis, Clinical interpretation and reporting, Validation and verification of laboratory-developed tests (LDTs), CLIA/CAP compliance activities, Reagent and instrument qualification
- Experience interacting with regulatory authority inspectors
- Experience preparing and supporting clinical study sites undergoing regulatory authority inspections
- Experience revising SOPs and procedures
- Medical Device experience is preferred
Benefits
- Career development
- Free medical coverage
- Retirement savings plan
- Tuition reimbursement
- Student debt program
- Education benefit
Company overview
Abbott Laboratories is a global healthcare leader with a 135-year legacy of innovation, dedicated to helping people live healthier, fuller lives through life-changing technologies and products. Headquartered in Abbott Park, Illinois, the company operates in more than 160 countries with a workforce of approximately 114,000 professionals. Abbott's diversified portfolio spans four core business segments: medical devices, diagnostics, nutrition products, and branded generic pharmaceuticals. The company is particularly renowned for its groundbreaking medical devices including cardiovascular technologies, diabetes management systems like the FreeStyle Libre continuous glucose monitor, neuromodulation devices for chronic pain, and the AVEIR DR dual chamber leadless pacemaker system. In diagnostics, Abbott has been instrumental in developing critical tests, including the first licensed HIV test in 1985 that helped secure blood supply safety. The company's nutrition division produces leading infant formulas like Similac, while its pharmaceutical business provides quality branded generic medicines. Abbott consistently ranks among Fortune's Most Admired Companies and maintains a strong commitment to sustainability and corporate responsibility, making it a trusted partner in advancing global healthcare.