Quality Assurance Specialist

Position Overview:
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.

Key Responsibilities:

• Adhere to safety protocols and regulatory standards including wearing Personal Protective Equipment (PPE), when necessary.
• Monitor Compliance: Ensure the laboratory adheres to regulatory standards, including CLIA, CAP, and OSHA guidelines, as well as state and federal requirements.
• Conduct Audits: Perform internal audits of laboratory processes and documentation to identify areas for improvement and ensure proper implementation of quality control measures.
• Incident Management: Help investigate non-conformities, discrepancies, or deviations from standard operating procedures (SOPs) and collaborate with laboratory staff to develop corrective actions and preventive measures.
• Training & Education: Assist in the development and delivery of training programs for laboratory personnel on quality assurance protocols, regulatory updates, and best practices in laboratory operations.
• Continuous Improvement: Support continuous improvement initiatives by identifying process inefficiencies, recommending solutions, and helping to implement changes that enhance laboratory performance and patient outcomes.
• Collaboration: Work with laboratory managers, supervisors, and technical staff to resolve quality issues and ensure smooth workflow.
• Data Analysis & Reporting: Collect and analyze quality data/indicators to be presented to laboratory leadership, providing insights and recommendations for maintaining high standards of operation.
• Risk Management: Assist in identifying, assessing, and mitigating risks related to laboratory quality, safety, and performance for new and existing processes.
• Update various technical documents, including work instructions, SOPs, equipment maintenance and calibration procedures, quality specifications, process flows, logistics procedures, and training materials.
• Complete additional tasks as assigned by management.

Qualifications and 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 compliance.
• Strong understanding of laboratory standards, including CLIA, CAP, NYS, and other relevant regulations.
• Familiarity 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.