Senior Clinical Laboratory Auditor

Abbott • Chicago, IL

5d • $113,300 - $226,700 • Onsite

About The Position

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 Abbotts Manufacturing and Clinical laboratory sites. Product quality and/or regulatory problems can negatively affect consumer health and safety, Abbotts worldwide image, performance of Abbott earnings and market share and customer confidence and loyalty. The role has a broad responsibility that has significant impact throughout AQR and all divisions. The position is responsible for ensuring executive management is aware of compliance business risks and regulatory requirements. 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. As a Senior Clinical Laboratory Auditor, you will lead Quality System audits and assessments according to regulations, standards, and Abbott procedures. You will participate in cross-divisional activities to integrate information from compliance audits, assessments and regulatory trends that may impact Divisions. The responsibility of the role includes proactive determination of regulatory, compliance, and quality issues, to integrate them into audits and assessments. This role requires highly effective communication and decision making with all levels of management as well as other division and corporate departments. The incumbent must be able to work independently without direct supervision or guidance and to exercise judgment in determining when complex issues merit Corporate Management involvement. Decisions must be made based on up-to-date regulatory knowledge, technical/business knowledge, and skills.

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

Nice To Haves

• Medical Device experience is preferred

Responsibilities

• 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.

Benefits

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior