Specialist Quality Assurance

Abbott•Lake Forest, IL

2d•$61,300 - $122,700

About The Position

About Abbott Diagnostic testing is a compass, providing information that helps in the prevention, diagnosis and treatment of a range of health conditions. Abbott’s life-changing tests and diagnostic tools give you accurate, timely information to better manage your health. We’re 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 Abbott’s 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 high‑quality service delivery to employer testing programs nationwide.

Requirements

Bachelor’s degree in Biology, Chemistry, Public Health, Quality Management, Regulatory Compliance, or related field preferred.
2–4 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.

Nice To Haves

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

Responsibilities

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 root‑cause analysis using structured problem‑solving 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 data‑driven insights to quality leadership and operational partners.

Benefits

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.