Columbia University Medical Center Job details Job Type Full-time Indeed's salary guide Not provided by employer $53.7K - $68.1K a year is Indeed's estimated salary for this role in New York, NY. Full Job Description Job Type: Officer of Administration Regular/Temporary: Regular Hours Per Week: 35 Position Summary The PGL combines next-generation sequencing in a CLIA and CAP-accredited laboratory to provide patients, families, and physicians with unprecedented information with which to make informed health decisions. The PGL enhances the University-wide, interdisciplinary, Precision Medicine Initiative by offering avenues for novel diagnostic genomics test development. The overarching mission of the PGL is to apply advanced genomic science in a clinically actionable setting to improve the diagnosis and treatment of human disease. The Laboratory Quality Assurance Specialist is responsible for the maintenance and oversight of the PGL QA program, proficiency testing, continuing education, occurrence reporting and compliance with all regulatory inspections and accreditation. Additional responsibilities include optimization of research workflows and quality assurance, as needed within the High Throughput Sequencing Facility at the Institute for Genomic Medicine (IGM). Responsibilities Proficiency Testing (College of American Pathologists, CAP): Ensure that the PGL is in compliance with the CAP Proficiency Testing requirements. This includes but is not restricted to: Place annual order to CAP, review surveys before submission and obtain personnel signatures post submission, obtain exceptions reports for review and signature by Director, file all surveys in the appropriate binders. Inspection and Accreditation - Review and update policy and procedure manuals as needed. Ensure all PGL staff have reviewed required policy and procedure manuals and signed off, as needed. Coordinate the CAP Self-Inspection with Department of Pathology & Cell Biology. Obtain copy of licenses annually or upon expiration from NYS and CAP. Act as one of primary contacts for laboratory in interactions with regulatory agencies. Quality Assurance and Quality Improvement - Collect, evaluate and distribute lab related quality tracking and trending data, i.e, test volumes, turn-around time, test failure rates and amendment rates and ensure prompt and regular communication to Faculty and management. Prepare and present monthly review and troubleshooting of quality metrics to Faculty and Management. Track and monitor laboratory equipment’s service contracts for calibrations and preventative maintenance scheduling. Work/collaborate with the PGL Laboratory Manager to ensure a unified reporting style and tracking system. Continually monitor applicable lab performance indicators and develop corrective and preventive action plan when non-conformities are discovered. Optimization of research workflows and quality assurance within the High Throughput Sequencing Facility at the Institute for Genomic Medicine (IGM) Maintain accurate documentation in accordance with internal and external regulatory agencies; ensure all SOPs are up to date, adherence to established protocols have been met and are in compliance with CAP and NYSDOH standards for all assays. Organize activities necessary for monitoring personnel training and competency assessment. Develop proficiency in all laboratory assays in order to assist and/or fill in for laboratory personnel, as needed. Perform bench work when needed. Be back up for PGL laboratory manager, as needed. Participate in internal and external quality audits as directed by Management. Participate in the hospital and university joined weekly QA meeting. All other related duties as assigned. Minimum Qualifications Requires a bachelor's degree or equivalent in education and experience, plus three years of related experience.