Job Description

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

PROFESSIONAL REQUIREMENTS

• 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
• High level of attention to detail

EDUCATION 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 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
• Previous experience with laboratory information systems preferred

KNOWLEDGE, SKILLS AND ABILITIES

• 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
• Ability to function independently and in a team environment

PHYSICAL REQUIREMENTS

• 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)
• Position requires sitting, walking, reaching, bending, stooping, and handling objects with hands and/or fingers, talking and/or hearing, and seeing

DIRECT REPORTS

• Clinical Laboratory Technician

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