Job Description
Job Description
Description : 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
- Additional duties as assigned
Requirements :
PROFESSIONAL REQUIREMENTS
Regular and prompt attendanceAn advanced understanding of drug metabolism, toxicology, forensic testing, P450 enzymes, or testing principles specifically related to urine and oral fluid metabolismAn advanced understanding of LC-MS / MS systems and data interpretationProficient in operating complex laboratory instrumentation and computers with scientific softwareAbility to participate in method development, validation or research with Technical Supervision preferredAble 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 experienceMust 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 policiesMust be able to achieve superior results when work is reviewed in terms of quality, volume, timeliness, and adherence to established methods, standards and policiesParticipate in ongoing training and continuing education courses related to drug metabolism, toxicology, and LC-MS / MS systemsMust be able to supervise a team, communicate to all team members, and organize day-to-day responsibilitiesMust be able and willing to wear personal protective equipment (PPE) when requiredProficient with Microsoft Office applicationsAbility to multitask in a fast-paced environment, organize and prioritize work as neededCan recognize problems with instrumentation and samples that could impact resultsCommunicates effectively with both internal and external customersHigh level of attention to detailEDUCATION AND EXPERIENCE REQUIREMENTS
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 experienceAt least 1 year of supervisory experience requiredPreference for candidates with familiarity of LC-MS / MS instrumentationPreference for candidates with familiarity with Agilent MS and LC systems – specifically MassHunter Acquisition and Quantitation ProgramsPrevious experience with laboratory information systems preferredKNOWLEDGE, SKILLS AND ABILITIES
Ability to communicate effectively, orally and in writingDemonstrated leadership abilityAbility to coordinate laboratory functions and represent the toxicology laboratory professionallyExcellent time management, scheduling, documentation, and organizational skillsDemonstrated troubleshooting abilitiesMust be flexible, innovative, and self-motivatedAbility to function independently and in a team environmentPHYSICAL REQUIREMENTS
Work is performed in a laboratory environment and exposes the incumbent to normal laboratory hazards and chemicals, including biohazard materialsWork in varying degrees of temperature (heated or air conditioned)Position requires sitting, walking, reaching, bending, stooping, and handling objects with hands and / or fingers, talking and / or hearing, and seeingDIRECT REPORTS
Clinical Laboratory Technician