Lab QA Consultant

Job Summary:

As the Quality Assurance Consultant at Tribal Diagnostics, you will play a pivotal role in monitoring and managing the quality management (QM) program and ensuring that our diagnostic services consistently meet the highest standards of quality and compliance with CAP/CLIA requirements. You will oversee comprehensive reviews of laboratory processes, equipment, documentation, and staff competencies. Your expertise will ensure that all aspects of the laboratory operations adhere to best practices and regulatory requirements, safeguarding the integrity of our diagnostic services.

Duties/Responsibilities:

• Competency and Training Reviews: Oversee and review documentation of Laboratory Director and staff competencies, including completion of higher learning degrees, attainment of certifications, and work competency checkoffs.
• Test Menu and Proficiency Testing: Review the laboratory’s test menu and the results of proficiency testing for all items, ensuring accuracy and compliance.
• Testing Validations: Review validations for each item on the testing menu, ensuring proper documentation and director sign-off.
• Equipment Calibration and Quality Control: Conduct reviews of annual and bi-annual equipment calibrations and daily quality control documentation to maintain testing accuracy.
• ensure that established testing and quality control acceptability are being adhered to by laboratory personnel and that all procedures in place at Tribal are in compliance with CAP/CLIA requirements
• Log Sheet Review: Ensure accurate and up-to-date documentation on log sheets, including temperature monitoring and equipment maintenance.
• Internal Audit Oversight: Review internal audit documentation covering specimen collection, handling, accessioning, data transfer, and final reporting processes.
• This individual is responsible for assuring that all quality assurance indicators of quality cover all areas of the laboratory and all beneficiaries of service.
• Critical Results Reporting: Evaluate and ensure the adequacy of policies for critical results reporting.
• Standard Operating Procedures (SOPs): Review and ensure all SOPs reflect the duties and responsibilities of the entire laboratory staff accurately and are up-to-date.
• Monitor and manage the Quality Management Program pertaining to pre-analytic, analytic, and post-analytic processes.
• Safety Reviews: Conduct thorough reviews of all safety elements within the laboratory workspace, including training and education, to ensure a safe working environment.
• Follow strict safety procedures when handling toxic and biohazard materials to avoid contamination
• Develop and implement quality assurance policies and procedures to ensure compliance with regulatory standards.
• Train and mentor staff on quality assurance best practices and regulatory requirements.
• Review and analyze quality data to identify trends and areas for improvement.
• Prepare and present quality reports to management, highlighting key findings and recommendations.
• Stay updated with the latest regulations, standards, and industry trends related to quality assurance in diagnostics.
• Assist all Laboratory Staff in maintained documents and records for analyzing data and identify issues and write corrective and preventive actions
• Schedule and run monthly, quarterly and annually Quality assurance meeting with leadership to discuss quality controls, indicators, PTs and present findings.
• Assist in the development and maintenance of a quality management system (QMS) that aligns with industry standards.
• Prioritize projects such as lab relocation and documentations to meet regulatory requirements for all departments.
• Comply with additional duties as assi