Description

JOB OVERVIEW

Ethos Laboratories, Massachusetts facility, is CLIA-certified clinical diagnostic testing facility. The Supervisor Core Lab 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 data analysis and report certification meets established turnaround time (TAT) requirements.

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 urine specimens on LC-MS/MS instrumentation
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 CAP/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 HIPPA 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 CAP preparation, inspections and compliance
Orient new employees
Participate and perform employee competencies
Additional duties as assigned

Requirements

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

Master’s Degree in Life Science, Pharmacology, Toxicology, Biology, Physics, or similar analytical science field with 1 year of related experience, or Bachelor of Science with 2-3 years of relevant 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; familiarity with Windows software applications a plus

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