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Customer Tools Specialist
bioMerieux Inc. | |
United States, Utah, Salt Lake City | |
April 29, 2024 | |
Description Job Summary The Customer Tools Specialist supports development of tools that simplify for customers the process of onboarding new bioMerieux molecular IVD tests and demonstrating routine regulatory compliance. These tools include Verification and Proficiency testing materials and associated protocols and customer-facing literature. This position is primarily responsible for hands-on testing of materials, data analysis, data presentation, and reporting of results. The position has some collaboration with outside manufacturers regarding the technical development and monitoring of external QC, Verification, and Proficiency Testing materials used by bioMerieux customers as well as drafting literature and monitoring issues with those materials; this may include testing of materials and recording of data in accordance with established protocols and work instruction documents, regulations, safety requirements, and the quality system. Knowledge/experience regarding US regulatory guidelines associated with the use molecular diagnostics is desired. Familiar with a variety of the field's concepts practices, and procedures including nucleic acid preparation, PCR, RT-PCR, real-time PCR, and use of fluorescence-based nucleic acid detection techniques. May supervise the work of others. Essential Job Duties and Responsibilities 1. Performs all work for assigned projects/experiments in compliance with company policies and within the guidelines of the company's Quality System. 12. Maintains a broad knowledge of state-of-the-art principals and theories. Supplemental Data * Performs work independently. Training and Education * Bachelor's or Master's degree in a scientific discipline. Experience * A minimum of 5+ years' experience in an academic, industry, or healthcare laboratory. Knowledge, Skills, and Abilities * Has working knowledge of current and evolving microbiology and molecular biology principles, tools, and techniques relevant to developing diagnostic tests for infectious diseases. * Advanced understanding of molecular diagnostics and their use in CLIA-mod/-waived regulatory settings. Physical Requirements * Must be able to lift and safely maneuver 40 lbs. |