Supervisor Core Lab (Toxicology/Drug Testing)
hace 18 días
Worcester
Job DescriptionDescription: JOB OVERVIEW Ethos Laboratories, Massachusetts facility, is a CLIA-certified clinical diagnostic testing facility. The Supervisor is primarily responsible for the day-to-day operation of the Core Lab. They will ensure that all patient sample accessioning, preparation, toxicological analysis using EIA and LC-MS/MS instrumentation, and report releasing occurs according to established SOPs. In addition, they will primarily operate and maintain LC-MS/MS instrumentation and ensure that chromatographic data analysis and report certification meets established turnaround time (TAT) requirements and CLIA regulations. ESSENTIAL FUNCTIONS • Supervise Clinical Laboratory Technician(s) and all testing processes including accessioning, sample preparation, screening, and confirmatory toxicological testing at Core Lab, • Guide the day-to-day workflow of the lab and the Clinical Laboratory Technician(s), • Prepare, run, and analyze chromatographic data from urine specimens on LC-MS/MS instrumentation for 50+ drugs, • Maintain, troubleshoot, and operate LC-MS/MS instrumentation, • Interpret, analyze, and release patient toxicological reports using EIA and LC-MS/MS instrumentation, • Prepare solutions for LC – requiring candidate to perform calculations related to basic chemistry, such as molarity, buffers, dilutions, etc.; also requires appropriate documentation of solutions prepared, opened, and filled, • Wash used reagent bottles/glasses/graduated cylinders, • Update MS for changes in methods, test menus, or changes in testing consumables, such as columns, solvents, etc. – requiring tracking maintenance repairs and monitoring use of consumables to stay within budgets, • Execute the successful tuning and calibration of LC-MS/MS systems, identify system errors, troubleshoot tuning/calibration errors, and work in close contact with Laboratory Director to correct instrumentation errors, • Prepare daily work lists for all methods and all matrices, ensuring accuracy of methods and most efficient use of instrument time, • Work on selected projects as determined by the Laboratory Director, and meet all established deadlines and project goals, • Review and certify patient reports following established protocols – specifically for urine testing – utilizing and reporting point of care testing, EIA screening, and LC-MS/MS confirmation testing results, • Answer incoming phone calls from customers, including questions regarding basic toxicology, basic drug metabolism, assistance with report issues, and sending reports, • Coordinate with Newport lab for data analysis and/or certifying reports support when necessary, • Complete internal and external rerun requests, • Review calibration and quality control data for each batch of patient samples, • Utilize established protocols to confirm retention time, precursor and product ions, and qualifier ions are within established ranges for peak qualification and note any discrepancies, • Identify patient samples requiring reinjections or re-extractions following established protocols, • Assist in proficiency testing, monitoring of daily controls, and be responsible for operating within the established quality controls parameters; including the recognition of invalid data and bringing all errors to the supervisor’s attention, • Adhere to CLIA compliance standards, • Participate in developing new testing opportunities and method development as needed, • Prepare quality controls and calibrators from certified standard materials, • Prepare reports of technological findings by collecting, analyzing, and summarizing information. Participates in Proficiency Testing of unknown samples according to Laboratory’s policy for testing survey samples., • Maintain safe and clean working environment by complying with procedures, rules, and regulations., • Protect patients and employees by adhering to infection-control and hazardous waste policies and protocols; follows patient identification procedures., • Adhere to HIPAA and PPE Policies, and Office Rules (Maintains patient confidentiality, and protects the clinic by keeping private information confidential.), • Create staff schedules, organizes workloads and assigns duties to staff, including securing sufficient coverage, • Participate in hiring, evaluation and training of new employees, • Monitor TAT for Core Lab tests and KPIs for Core Lab employees, • Participate in inspections and compliance, • Orient new employees, • Participate and perform employee competencies, • Regular and prompt attendance, • An advanced understanding of drug metabolism, toxicology, forensic testing, P450 enzymes, or testing principles specifically related to urine and oral fluid metabolism, • An advanced understanding of LC-MS/MS systems and data interpretation, • Proficient in operating complex laboratory instrumentation and computers with scientific software, • Ability to participate in method development, validation or research with Technical Supervision preferred, • Able and willing to follow established protocols employing acceptable forensic standards of analysis and the use of judgment in searching for solutions or new applications within one’s own experience, • Must be able to work with limited supervision where the work assignments are subject to established procedures, practices, precedents, methods, techniques, standards, and/or well-defined policies, • Must be able to achieve superior results when work is reviewed in terms of quality, volume, timeliness, and adherence to established methods, standards and policies, • Participate in ongoing training and continuing education courses related to drug metabolism, toxicology, and LC-MS/MS systems, • Must be able to supervise a team, communicate to all team members, and organize day-to-day responsibilities, • Must be able and willing to wear personal protective equipment (PPE) when required, • Proficient with Microsoft Office applications, • Ability to multitask in a fast-paced environment, organize and prioritize work as needed, • Can recognize problems with instrumentation and samples that could impact results, • Communicates effectively with both internal and external customers, • Bachelor of Science in Life Science, Pharmacology, Toxicology, Biology, Physics, or similar analytical science field with 2-3 years of relevant experience; or Master’s Degree with 1 year of related experience, • At least 1 year of supervisory experience required, • Preference for candidates with familiarity of LC-MS/MS instrumentation, • Preference for candidates with familiarity with Agilent MS and LC systems – specifically MassHunter Acquisition and Quantitation Programs, • Ability to communicate effectively, orally and in writing, • Demonstrated leadership ability, • Ability to coordinate laboratory functions and represent the toxicology laboratory professionally, • Excellent time management, scheduling, documentation, and organizational skills, • Demonstrated troubleshooting abilities, • Must be flexible, innovative, and self-motivated, • Work is performed in a laboratory environment and exposes the incumbent to normal laboratory hazards and chemicals, including biohazard materials, • Work in varying degrees of temperature (heated or air conditioned), • Clinical Laboratory Technician