Quality Assurance Specialist 1 - Clinical Lab

The Quality Assurance Specialist I is responsible for supporting, coordinating, and executing quality assurance activities at the local department or facility level. Under the guidance of QA leadership, this role assists in ensuring that all pre-analytical, analytical, and post-analytical processes are consistent with Quest Diagnostics' standard operating policies and procedures. This role focuses on data collection, maintaining databases, auditing departmental activities licensure support, investigations, regulatory compliance activities, tracking employee training and competency records and ensuring inspection readiness.

The QA Specialist I position is hybrid and can work from the Quest/Corewell hospital lab based in Grand Rapids or Royal Oak, MI. The team will consider additional Quest/Corewell lab sites depending on a candidate's location in MI. 

Required Work Experience

• 1+ year in a Clinical Laboratory setting or healthcare/life sciences.

Preferred Work Experience

• 1+ years of exposure to basic quality systems, point of care coordination, or specimen processing QA.
   

Physical and Mental Requirements

• Primarily an office-based position requiring extensive screen time, report generation, and meeting leadership. Ability to walk and stand in laboratory environments during audit processes. Occasional lifting, up to 20 lbs.

Knowledge

• Basic working knowledge of laboratory regulations and standards (i.e., CMS, CAP, CLIA) and the accreditation processes.
• Working understanding of Laboratory Information Systems (LIS).
• Proficiency in Microsoft Office applications (Word, Excel, Outlook, Teams).

Skills

• Detail-oriented.
• Strong organizational and prioritization skills.
• Effective verbal, written, and interpersonal communication skills.
• Ability to track and closely monitor records management.
• Ability to interact collaboratively with lab management and influence change and outcomes.
• Intermediate analytical and problem-solving skills.

Work Environment

• Professional corporate office and clinical laboratory environment. Active biohazard precautions as required when accessing clinical laboratory areas.

Occasional travel between Quest/Corewell sites required. 

Education

• BS/BA in Medical Technology, Chemistry, Biology, or related Science field. (Required)

Technical Training or Professional Licensing

• State clinical laboratory licensure and/or certification where applicable, required.
• ASCP (MLT/MT) or equivalent, preferred.

Strategic Quality Management

• Collects, tracks, and supports monthly departmental Quality Indicators and daily management system data.
• Assists with monitoring data collection for performance reportables.
• Formats and presents data summaries to key stakeholders.

Compliance & Audit Management

• Conducts routine internal, audits including in laboratory inspection/GEMBA and desk audits; documents observations and recommendations.
• Prepares for external inspections (CAP, CLIA, etc.) and may support safety standard oversight.
• Gathers data for report approvals and processes QA payments/invoices for key materials such as proficiency testing surveys.

Continuous Improvement

• Performs routine QA data pulls and tracks quality trends.
• Flags local issues (revised reports, complaints) and supports quality investigations / quality event investigations and inquiries.
• Executes non-complex corrective actions.
• Performs data transmission electronic interface tests as required.

Quality Systems Oversight

• Assists with document control program including enterprise software applications.
• Supports local SOP routing, forms development and distribution.
• Tracks PT enrollment, compiles results, executes PT processes (e.g., ordering, cancelling), and supports comparison studies.
• Supports basic tasks and reviews competency completion and identifies gaps.
• Periodic assessment activities such as monitoring equipment issues, preventative maintenance, temperature logs, water cultures, validation reviews, and routine laboratory activities.
• Supports government agency reporting as needed.

Other duties

• Other duties as assigned to meet business needs. This is not an exhaustive list of all duties and responsibilities, but rather a general description of work performed by the position.