Specialist Quality Assurance

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 114,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: About Abbott Diagnostic testing is a compass, providing information that helps in the prevention, diagnosis and treatment of a range of health conditions. Abbotts life-changing tests and diagnostic tools give you accurate, timely information to better manage your health. Were empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbotts diagnostics instruments, providing lab results for millions of people. The Opportunity The Quality Assurance Specialist supports the US Workplace Services team within RMDx Toxicology by ensuring operational processes, documentation, and workflows comply with applicable Department of Transportation (DOT), Health and Human Services (HHS), and New York State regulatory requirements. This role ensures accuracy, data integrity, and compliance across all non-laboratory toxicology program functions, enabling highquality service delivery to employer testing programs nationwide. What You'll Do Maintain and support the Quality Management System (QMS) aligned with DOT 49 CFR Part 40, HHS Mandatory Guidelines, and New York State Department of Health (NYSDOH) requirements. Draft, revise, and manage controlled quality documents including SOPs, forms, and work instructions. Support implementation of controlled document updates and regulatory-driven process changes. Perform quality control reviews for medical device complaint intake documentation to ensure accuracy, completeness, and compliance with internal standards and applicable regulations. Verify that complaint records are properly triaged, categorized, and documented according to established procedures. Ensure timely routing of complaints to appropriate stakeholders, including Legal Manufacturer. Support preparation of complaint-related metrics, summaries, and audit-ready documentation. Assist in maintaining alignment with FDA 21 CFR Part 820 (as applicable for complaint handling), company-level complaint procedures, and internal reporting requirements. Support internal and external audits for DOT, HHS, NY State, and customer compliance needs. Conduct routine quality checks of non-laboratory processes such as specimen handling, chain of custody workflows, program documentation, and reporting procedures. Track findings, corrective actions, and follow-up activities to maintain a continuous state of readiness. Investigate quality incidents, nonconformances, and customer-impacting events. Initiate and verify corrective and preventive actions (CAPA) for effectiveness and timely closure. Perform rootcause analysis using structured problemsolving methods. Review chain-of-custody forms (CCFs), custody records, processing documentation, and other toxicology program data for completeness and accuracy. Validate that workflows for specimen receipt, tracking, routing, and reporting meet DOT/HHS/NY requirements. Partner with operations teams to ensure proper execution of testing program processes. Maintain training and competency records for staff supporting regulated toxicology programs. Assist in developing training materials for compliance updates or quality system enhancements. Identify and support process improvement opportunities to reduce risk and enhance quality. Prepare reports, trend analyses, and KPIs for deviations, CAPAs, audit observations, and quality indicators. Present datadriven insights to quality leadership and operational partners. Required Qualifications Bachelors degree in Biology, Chemistry, Public Health, Quality Management, Regulatory Compliance, or related field preferred. 24 years of experience in quality assurance or compliance within a regulated environment (toxicology programs, workplace drug testing, healthcare administration, or related). Working knowledge of: DOT 49 CFR Part 40 HHS Mandatory Guidelines for Federal Workplace Drug Testing Programs New York State Department of Health toxicology requirements Strong documentation, analytical, and organizational skills. Ability to work cross-functionally and communicate effectively. Preferred Qualifications Experience supporting workplace drug testing programs or toxicology operations (non-lab or lab-adjacent). Familiarity with chain-of-custody workflows and specimen tracking requirements. Experience with quality event management systems, electronic QMS, or LIMS. ASQ certification or similar credentials in quality or regulatory compliance What We offer At Abbott, you can have a good job that can grow into a great career. We offer: A fast-paced work environment where your safety is our priority Production areas that are clean, well-lit, and temperature-controlled Training and career development, with onboarding programs for new employees and tuition assistance Financial security through competitive compensation, incentives, and retirement plans Health care and well-being programs including medical, dental, vision, wellness, and occupational health programs Paid time off 401(k) retirement savings with a generous company match The stability of a company with a record of strong financial performance and a history of being actively involved in local communities Learn more about our benefits that add real value to your life to help you live fully: http://www.abbottbenefits.com/pages/candidate.aspx Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. 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 @AbbottNews and @AbbottGlobal The base pay for this position is $61,300.00 $122,700.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY: Operations Quality DIVISION: TOX ARDx Toxicology LOCATION: United States > Lake Forest : J55 ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: No MEDICAL SURVEILLANCE: Not Applicable 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 its 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 lifes 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