JOB SUMMARY: Under the supervision of the Technical or General Supervisor, responsible for specimen processing, performing a full range of laboratory tests and reporting laboratory findings in a non-supervisory position. Performs only those high complexity tests that are authorized by the laboratory director and require a degree of skill commensurate with the individual's education, training or experience, and technical abilities.

DUTIES AND RESPONSIBLITIES:

• Apply the principles, theory and techniques of LC-MS/MS-based drug testing to identify the presence or quantity of drugs of abuse, therapeutic drugs and toxic substances; in human biological specimens such as oral saliva, urine, dried blood, plasma etc.
• Reviewing TargetLynx data obtained from the LC-MS/MS instrumentation and monitoring test analyses to ensure that acceptable levels of analytic performance are maintained.
• Perform results entry into Laboratory Information System (LIS) and approving the final results into Advantage Reporting UI after a comprehensive data review.
• Adhere to the laboratory’s quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed.
• Maintain quality results by running standards and controls, verifying equipment function through routine equipment maintenance and advanced trouble shooting; calibrating equipment utilizing approved testing procedures.
• Perform, interpret and record quality control as appropriate and record corrective action(s) where appropriate.
• Identify and communicate adverse instrument and/or data-related events by alerting supervisory personnel, the lab director, the provider, and/or management; reporting mandated information to the public health department or other designated officials.
• Follow the laboratory’s established policies and procedures whenever test systems deviate or are not within the laboratory’s established acceptable levels of performance specifications.
• Candidate must be capable of identifying problems that may adversely affect test performance or reporting of test results and either must correct the problems per SOP or immediately notify the general supervisor, technical supervisor and lab director.
• Assure that patient test results are not reported until all corrective/remedial actions have been taken, documented and the test system is properly functioning.
• Document all corrective actions taken when test systems deviate from the laboratory’s established performance specifications.
• Maintain records that demonstrate that proficiency testing samples are tested in the same manner as patient specimens.
• Participate in available continuing education and maintains licensure/certification as required by State law and accreditation agencies.
• Provide an analytical approach to technical resolutions by participating in staff training; answering questions of other professionals; participating in educational opportunities; and maintaining licensure and certification as required by the company, State/local laws and accrediting bodies.
• Contribute to a safe and secure environment for co-workers and all others by following established standards and procedures; complying with legal regulations and maintaining patient confidentiality.
• Serve and protect the community by adhering to professional standards; policies and procedures; federal, state, and local requirements; and
• Other duties may include but are not limited to;
• Specimen handling and processing- Analyze and organize work by matching computer orders with specimen labeling; sorting specimens; checking labeling; logging specimens; arranging reports for delivery; keeping work surfaces clean and orderly
• Sample extraction, sample loading onto LC-MS/MS instruments, building sample lists and starting runs.
• Ensuring instrument availability by accessing and logging information pertaining to instrument status, maintenance performed; on Microsoft Sharepoint.
• Knowledge of proper specimen collection procedures, including patient preparation, labeling, handling, preservation, processing, preparation, transportation and storage of specimens.
• Maintain and verify the documents required for Laboratory Director’s visit, documentation and read and sign sheets.
• By coordinating with the Technical Supervisor, maintain records per accreditation, state, local and federal guidelines. Such records include but are not limited to test logs, error logs, QC reports, proficiency testing, and discontinued procedures.
• Manage cumulative quality assurance data.
• Meets with Laboratory Manager (General/Technical Supervisor) and Laboratory Director at least twice a year for Quality Assurance updates, education and update and review of CLIA regulations.
• Must be accessible to testing personnel at all times when testing is performed to provide on-site, telephone, or electronic consultation to document technical problems in accordance with policies and procedures established by the Laboratory Director or Technical Supervisor.
• Review of quality control records, proficiency testing results and maintenance records.
• Other duties may be assigned.
• Inspection/Audit/Surveyor: Expectation is labs should be prepared and operate on a day to day basis to result in no deficiencies on any scheduled, random or unannounced inspection from any accrediting agency including but not limited to CLIA, COLA, OSHA, Department of Health, State, etc. Participate in required reciprocal Inspections as needed and/or requested by the Technical Supervisor. 

Education:

• Bachelor’s/Master’s degree in Chemistry, Biological or Physical Sciences or Medical Technology.
• Must possess chromatography experience with hyphenated instrumentation such as GC-MS, LC-MS and/or LC-MS/MS.

Experience:

• Minimum 3 years of experience in clinical chemistry, toxicology with Bachelor’s degree.
• Minimum 3 months to 1-year of experience in clinical chemistry, toxicology with Master’s degree.

Professional License:

• Possess or be able to obtain Clinical Laboratory Scientist (CLS), Medical Technologist (MT, Clinical Chemistry) or equivalent State license(s)/certification(s) for position as required by State Law and laboratory within four (4) months of hire.
• Certifier must at minimum meet the personnel responsibilities qualifications per CLIA Sec. 493.1495 1489 Standard: Testing Personnel Responsibilities Qualifications, as well as any and all State licensure/certification requirements for the position.

Skills:

• Ability to communicate in English, written and verbally, with peers and management.
• Average computer skills for creation and maintenance of policies and procedures, spreadsheets, chart and graphs, and data management.
• Ability to create and present presentations to small and large groups.
• Advanced skill in Microsoft Office Products (Excel, Word, PowerPoint, Outlook) and Adobe Acrobat.
• Ability to perform, create and interpret statistical data for validations, correlations, etc.
• Basic math skills; Ability to create and work with statistical data.
• Ability to quickly learn proprietary software programs.
• High degree of confidentiality.

Work Environment and Physical Demand:

• Potential exposure to blood and body fluid: Category I – Performs tasks which involve exposure to blood, body fluid, or tissue
• General office and lab environment. No special physical demands required.
• Willing to work a flexible schedule as needed.
• Some travel to customer sites or partners may be required (<10%).