Quality Assurance Specialist

Access Medical Labs is one of the largest specialty diagnostic labs in the country, using 50% less blood and delivering next-day results. We offer a comprehensive test menu—from routine panels to advanced biomarkers—across blood, saliva, and urine, performing over 1,000 tests under one roof. Our ultra-automated facilities, spanning over 55,000 sq. ft., are powered by the most cutting-edge diagnostic technology and innovative lab logistics available.Since 2003, we’ve been committed to delivering a truly exceptional client experience backed by precise and reliable testing. Every innovation we pursue is driven by one purpose: making personalized medicine more practical and accessible.Company culture is the foundation of Access Medical Laboratories. We continue to attract mission-driven and goal-oriented professionals to our organization, where each individual and team is recognized for their accomplishments. We place a significant amount of value on teamwork and mentorship, enabling each individual to consistently grow and develop. At Access, each team member has a sense of belonging, family, and community. We enjoy coming to work every day in an environment where people feel empowered, understanding that each team member plays a significant role in providing peace of mind to patients nationally. Job Summary: The Quality Assurance (QA) Specialist is responsible for ensuring the highest standards of quality in the diagnostic testing processes within the laboratory. The ideal candidate will focus on monitoring, assessing, and enhancing laboratory practices to maintain compliance with regulatory standards, ensure accurate test results, and optimize overall laboratory operations. The QA Specialist will work closely with laboratory staff to promote a culture of quality and continuous improvement.Job Responsibilities:Adhere to safety protocols and regulatory standards including wearing Personal Protective Equipment (PPE), when necessaryMonitor Compliance: Ensure the laboratory adheres to regulatory standards, including CLIA, CAP, and OSHA guidelines, as well as state and federal requirementsConduct Audits: Perform internal audits of laboratory processes and documentation to identify areas for improvement and ensure proper implementation of quality control measuresIncident Management: Help investigate non-conformities, discrepancies, or deviations from standard operating procedures (SOPs) and collaborate with laboratory staff to develop corrective actions and preventive measuresTraining & Education: Assist in the development and delivery of training programs for laboratory personnel on quality assurance protocols, regulatory updates, and best practices in laboratory operationsContinuous Improvement: Support continuous improvement initiatives by identifying process inefficiencies, recommending solutions, and helping to implement changes that enhance laboratory performance and patient outcomesCollaboration: Work with laboratory managers, supervisors, and technical staff to resolve quality issues and ensure smooth workflowData Analysis & Reporting: Collect and analyze quality data/indicators to be presented to laboratory leadership, providing insights and recommendations for maintaining high standards of operationRisk Management: Assist in identifying, assessing, and mitigating risks related to laboratory quality, safety, and performance for new and existing processesUpdate various technical documents, including work instructions, SOPs, equipment maintenance and calibration procedures, quality specifications, process flows, logistics procedures, and training materialsComplete additional tasks as assigned by managementQualifications & Skills:Bachelor's degree in Clinical Laboratory Science, Medical Technology, or a related field (or equivalent combination of education and experience)Minimum of 2-3 years of experience in a laboratory, healthcare, or pharmaceutical environment, with a focus on quality assurance or regulatory complianceStrong understanding of laboratory standards, including CLIA, CAP, NYS, and other relevant regulationsFamiliarity with laboratory information management systems (LIMS) and quality management systems (QMS).Basic knowledge of Microsoft programs (Word, Excel, PowerPoint, OneNote, etc.)Excellent attention to detail, organizational skills, and ability to handle multiple tasks.Strong communication and interpersonal skills to collaborate with staff at all levels.Ability to analyze data, interpret results, and make data-driven decisions.Ability to write clearly and informatively and ability to read and interpret written information.Certification as a Medical Laboratory Technician (MLT) or Medical Laboratory Scientist (MLS) is preferred but not required.