Certifying Scientist LC-MS/MS Toxicology

JOB OVERVIEW

The Certifying Scientist is responsible for the quantitation of LC-MS/MS data and certification of laboratory result reports for drug testing and/or biomarker testing in patient specimens. This role engages in professional work in conducting toxicological examinations to identify and quantify target compounds following established policies, procedures, and CAP/CLIA regulations. This role also participates in validation studies, proficiency testing programs, method development, and other programs at the direction of the Laboratory Manager. In addition, this role interacts directly with clients and the Sales team to assist with report questions and issues.

ESSENTIAL FUNCTIONS

• Perform LC-MS/MS data analysis using mass spec software with multi-analyte methods to evaluate acceptability of calibration, quality controls (QCs), negative controls, and patient specimen data following established standard operating procedures (SOPs)
• Utilize established and acceptable standards, as well as experience and knowledge, when reviewing chromatographic data
• 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
• Review and document calibration and QC data for each batch of patient specimens
• Identify patient specimens requiring reinjections or re-extractions following established protocols
• Program reinjections to run on the LC-MS/MS instruments
• Document data analysis completed and items for further review
• Transmit completed data analysis to the Laboratory Information System (LIS)
• Transcribe data from first review onto final review list
• Identify and communicate trends or issues within batches of patient specimen data
• Identify and communicate trends or issues with LC-MS/MS instrument performance
• Review all laboratory 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 - due to the presence of non-prescribed medications and/or illicit drugs, as well as the absence of prescribed medications
• Add comments to final reports as needed
• Final review and certification of patient laboratory reports utilizing screen (preliminary) test data, medication lists, confirmation (definitive) test data, interpretive comments, and/or Director's Notes following established protocols
• 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 clients and the Sales team, including questions regarding basic toxicology, basic drug metabolism, assistance with report issues, and understanding how to read the laboratory report
• Escalate calls to the Laboratory Director when Clinical Consultations are required
• Complete and document internal and external rerun requests
• Complete and document updated and corrected reports as needed
• 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 attention of the Laboratory Manager
• Ensure adherence to all SOPs, policies, and CAP and CLIA regulatory requirements
• Other duties as assigned

• An advanced understanding of LC-MS/MS systems and chromatographic data interpretation
• An advanced understanding of drug metabolism, toxicology, forensic testing, P450 enzymes, or testing principles specifically related to urine and oral fluid metabolism
• High level of attention to detail
• Responsible for promoting a collaborative environment where communication is critical to the success of all teams
• Proficient in operating complex laboratory instrumentation and computers with scientific software
• 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 and willing to wear personal protective equipment (PPE) when required
• Proficient with Microsoft Office applications

• Backelor Degree in Chemistry, Pharmacology, Toxicology, Biology, Physics, or similar analytical science field
• Requires a minimum of 1 year of related experience in a high-complexity laboratory
• Requires experience with LC-MS/MS instruments and chromatographic data analysis
• 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

• Ability to communicate effectively, orally and in writing
• 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
• Ability to coordinate laboratory functions and represent the toxicology laboratory professionally

• 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

• None