Senior Clinical Laboratory Auditor

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

Benefits offered by this job

Free HIP PPO medical plan (next year)

High employer retirement contribution

Tuition reimbursement

Job summary

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

Qualifications

• 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

Responsibilities

• 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

Skills

Lead auditor certificate

GCP knowledge

Audit planning

Regulatory inspections

Quality systems auditing

Risk assessment

Analytical skills

Communication skills

Time management

Independent thinking

Education

Bachelor’s Degree in a scientific field

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life.

You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• 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.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

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, Abbott’s 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.

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.

Required Qualifications:

• 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.undefined
• 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.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter

The base pay for this position is $113,300.00 – $226,700.00. In specific locations, the pay range may vary from the range posted.

JOB FAMILY: Operations Quality DIVISION: AQR Abbott Quality and Regulatory LOCATION: United States > Abbott Park : AP52 ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 5 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.

We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

Follow Us: Facebook LinkedIn YouTube Twitter