Research and Development Supervisor jobs in the United States

Description

JOB OVERVIEW

The Clinical Laboratory Supervisor/Technician is responsible for the operation of the Beresh Pain Management Laboratory, under direction of the Laboratory Director, including urine toxicology testing by EIA and LC-MS/MS. This role will include specimen preparation, instrument maintenance, instrument operation, data analysis, and certifying lab reports according to established SOPs and CLIA regulations. This position requires a high level of attention to detail, the ability to multitask, and the ability to use, maintain, and troubleshoot high-complexity instrumentation. NOTE: Part-time role requires availability to process up to 90 specimens every week on Friday or Saturday (on-site), with data analysis and certifying to be completed every week on Saturday or Sunday (remote option available).

ESSENTIAL FUNCTIONS

• Perform all testing processes including specimen preparation, specimen testing by enzyme immunoassay (EIA), and specimen testing by liquid chromatography tandem mass spectrometry (LC-MS/MS) following established standard operating procedures (SOPs)
• Adhere to HIPAA and CLIA regulatory standards 
• Maintain, operate, and troubleshoot EIA and LC-MS/MS instrumentation
• Utilize the laboratory information system (LIS) for patient and instrument data management
• Wear personal protective equipment (PPE) as required for each step in the testing process
• Complete and document daily, weekly, monthly, and as-needed instrument/equipment maintenance 
• Complete and document room temperature, humidity levels, water system, and reagent/solvent preparation
• Complete and document EIA calibrators, quality controls (QCs), reagent refills, and temperature checks
• Interpret data from EIA calibrators, Pre-QCs, and Post-QCs to ensure acceptable results are produced; recalibrate and rerun QCs as needed per SOP
• Pipet (aliquot) accessioned urine specimens into appropriate barcode-labeled test tubes, retain vials, and 96-well plates using single-channel, variable-volume pipettes
• Load barcode-labeled test tubes on EIA instrument for testing
• Analyze data from EIA to ensure complete testing; identify and prepare specimens needing reruns
• Prepare urine specimens, calibrators, and QCs for testing in 96-well plates by adding internal standard and required reagents using multi-channel, variable-volume pipettes
• Execute the successful tuning and calibration of LC-MS/MS 
• Generate LC-MS/MS worklists from the LIS and format for the instrument software
• Load 96-well plates on LC-MS/MS instrument for testing; verify acceptable calibrator and QCs at the beginning of the worklist before running overnight
• Perform LC-MS/MS chromatography data analysis using instrument software, ensuring Pre-QC and Post-QC acceptable results for each batch of patient specimens; program reruns/reinjections as needed
• Review and approve quality control data in LIS for each batch of patient specimens
• Review EIA and LC-MS/MS patient data in LIS before certifying and releasing final lab reports
• Maintain inventory for all lab supplies, reagents, and consumables
• Prepare quality controls and calibrators from certified standard materials
• Prepare reagents/solvents for LC; requires performing basic chemistry calculations, such as molarity, buffers, dilutions, etc.; also requires appropriate documentation of solutions prepared, opened, and filled 
• Update MS for changes in methods, test menus, or testing consumables 
• Wash used reagent bottles, glassware, graduated cylinders 
• Dispose of urine specimens that have reached their retention date 
• Maintain a safe and clean working environment by complying with procedures, rules, and regulations
• Ensure appropriate certification/calibration for all lab equipment and instruments
• Schedule preventative maintenance (PM) when necessary, utilizing instrument service contracts 
• Complete routine analytical measurement range (AMR) studies and verification studies as needed
• Complete and submit proficiency testing (PT) samples in coordination with the Laboratory Director
• Communicate issues or concerns with the Laboratory Director in a timely manner
• Prepare monthly Levey-Jennings (L-J) charts for Laboratory Director review
• Participate in CLIA inspections as needed
• Complete general lab tasks as needed
• Additional duties as assigned

Requirements

PROFESSIONAL REQUIREMENTS

• High level of attention to detail 
• Ability to multitask, organize, and prioritize work 
• Proficient in operating complex laboratory instrumentation and computers with scientific software 
• Proficient in use of single-channel and multi-channel pipettes
• Ability to perform work following established SOPs to ensure the highest quality standards are maintained
• Effectively troubleshoot process and instrument issues using critical, strategic, and analytical thinking
• Can easily recognize problems with instrumentation and specimens that could impact results
• An understanding of LC-MS/MS systems and data interpretation 
• An understanding of drug metabolism, toxicology, forensic testing, P450 enzymes, or testing principles specifically related to urine and oral fluid metabolism 
• 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 
• Proficient with Microsoft Office applications

EDUCATION AND EXPERIENCE REQUIREMENTS

• Bachelor of Science Degree in Chemistry, Pharmacology, Toxicology, Medical Laboratory Science, or similar analytical science field required
• Requires a minimum of 2 years of experience in a high-complexity toxicology laboratory
• Requires experience with chromatography data analysis and certifying for urine toxicology
• Requires experience with LC-MS/MS and EIA instrumentation
• Preference for candidates with familiarity with Agilent LC-MS/MS and software, specifically MassHunter Acquisition and Quantitation Programs

KNOWLEDGE, SKILLS AND ABILITIES

• 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 function independently 
• Ability to coordinate laboratory functions and represent the toxicology laboratory professionally

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