Certifying Scientist

JOB OVERVIEW

The Certifying Scientist is responsible for the quantitation of MS data and the final review of patient data and patient reports and interacting with clients to assist with report issues, such as issuing new reports, updating patient demographic information, and similar concerns. Ethos manages clinical samples for diagnostic drug and metabolite confirmation analysis, and this candidate will engage in professional work in conducting toxicological examinations to identify and quantify target compounds. In addition, they will participate in validation studies, proficiency testing programs, method development, and other programs at the direction of the Confirmation Supervisor.

ESSENTIAL FUNCTIONS

• Final review and certification of patient reports following established protocols – specifically for urine and oral fluid testing – utilizing and reporting point of care testing, EIA screening, and LC-MS/MS confirmation testing results
• Transcribe data from first review onto final review list
• Review reports individually, checking for completion of all demographic information, all ordered tests, and that results correspond to established norms
• Identify and confirm prescribed medication vs. inconsistent reports – either due to the presence of non-prescribed medications or illicit drugs
• Add comments to reports as needed
• Document completed reports and items for further review
• Collaborate and communicate with other departments to maintain the highest quality standards for testing procedures
• Answer incoming phone calls to the Confirmation department from customers, including questions regarding basic toxicology, basic drug metabolism, assistance with report issues, and sending reports
• Complete internal and external rerun requests
• Final review of internal rerun requests
• Review calibration and quality control data for each batch of patient samples
• Perform data analysis on patient samples for multiple analytes using mass spec software programs
• 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
• Program reinjections to run on the mass spec instruments
• Document data analysis completed and items for further review
• Transmit completed data analysis to the Laboratory Information System (LIS)
• 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
• Complete updated reports as needed
• Ensure adherence to all regulatory requirements
• Other 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
• High level of attention to detail
• 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
• Responsible for promoting a collaborative and entrepreneurial environment
• Must be able and willing to wear personal protective equipment (PPE) when required
• Proficient with Microsoft Office applications

EDUCATION AND EXPERIENCE REQUIREMENTS

• Master’s Degree in Life Science, Pharmacology, Toxicology, Biology, Physics, or similar analytical science field or Bachelor of Science in similar field with 1 year of related experience
• Preference for candidates with familiarity with LC-MS/MS instruments (other experience in instrumental analysis of HPLC or LC-MS/MS of drugs in biological tissues may be acceptable)
• Preference for candidates with familiarity with Agilent MS and LC systems – specifically MassHunter Acquisition and Quantitation programs
• Previous work with bodily fluids – such as urine and oral fluid is preferred

KNOWLEDGE, SKILLS AND ABILITIES

• Ability to communicate effectively, orally and in writing
• Ability to coordinate laboratory functions and represent the toxicology laboratory professionally
• Excellent time management, documentation, and organizational skills
• Demonstrated troubleshooting abilities
• Must be flexible, innovative, and self-motivated
• Ability to plan and organize his/her work
• Ability to function independently and in a team environment
• Ability to listen, learn, and promote accountability and responsibility related to all processes

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

• None