Clinical Laboratory Scientist II

Job Description

Job Description

Position Summary:

The Clinical Laboratory Scientist (CLS) is responsible primarily for testing functions and assists in overseeing the day-to-day operations of the clinical laboratory under the guidance of the Laboratory Director and/or Director of Operations. The CLS will perform clinical laboratory tests in the pre-analytical, analytical, and post-analytical phases in a CLIA/CAP certified environment and will prepare reports for review and approval according to established procedures. Additionally, the CLS will assist in drafting technical documents and procedures and phasing in new reagent lots. They will also test quality control samples and assist with capturing and reviewing quality control metrics. Under the guidance of the CLS Laboratory Manager and Laboratory Director, the CLS will also support the validation of new equipment (IQ, OQ, PQ) and test methods.

Key Responsibilities and Duties:

• Perform a range of assays, from simple to complex, such as RNA-DNA isolation, PCR, reverse transcription PCR, microarray hybridization, and real-time PCR, following established protocols.
• Complete training on all SOPs related to the job function and adhere to all rules and protocols.
• Read and record critical assay dependent measurements.
• Perform daily analyses accurately within the assigned discipline.
• Prepare clinical specimens for testing and identify specimen related problems.
• Perform QC for reagents and chemicals and phase in of new lots and by using the SOPs.
• Review and approve Quality Control results.
• Identify problems that may adversely affect test performance or reporting of test results and immediately notify the CLS supervisor or Laboratory Director.
• Document all corrective actions taken when test systems deviate from the laboratory's established performance specification.
• Assist in preparing validation documentation for new tests and procedures as required.
• Maintain the laboratory in a clean, functional state by scheduling and performing equipment and instrument maintenance, calibration verification, and certification, and ensuring all activities are documented in logs or forms as required.
• Adhere to HIPAA guidelines to maintain the privacy and confidentiality of personal information.
• Consistently and independently perform the most complex level of clinical tests.
• Perform newly introduced tests to the laboratory that require defined skills.
• Effectively resolve common problems or able to check with group leaders when it is uncertain.
  • Recognize and take appropriate action in response to critical values or unusual or unexpected results, and document action taken.
  • Can function as General Supervisor according to the CAP checklist.
  • Additional duties as directed, include but are not limited to:
  • Create and update laboratory schedule, including, but not limited to, assignment of testing personnel, instrument and equipment maintenance, reagent and instrument qualification events, training, competency assessment and proficiency testing.
  • Review quality assurance and control records, including batch records, test system quality control indicators, instrument maintenance, comparison, and qualification, reagent qualification, deviations, training, competency, and proficiency testing records.
  • Address and troubleshoot any technical problems or deviations within the test systems in the laboratory.
  • Assist or support in the transfer of new laboratory processes into the laboratory for production and, act as subject matter expert as needed.

Requirements:

Education/Certification

• B.S. degree is required in molecular biology, biological sciences, or a related field.
• Current California license as a Clinical Laboratory Scientist (CLS) Generalist and/or Clinical Genetic Molecular Biologist Scientist (CGMBS) required.

Experience:

• 4-6 years of experience in patient sample testing and related laboratory duties in a CLIA-regulated environment.
• Must possess relevant molecular skill set consisting of the molecular fundamentals, RNA and DNA extraction, PCR, reverse transcription, and gel electrophoresis.
• 2-3 years of experience in a molecular laboratory.
• Demonstrate clear ability to explain experience with specific instrument platforms, including test principle(s), what controls were in place, and how results were interpreted and reported out.

Physical Demands and Working Conditions:

The physical demands described below are representative of those that must be met by an employee to successfully perform the essential functions of this job. This job entails regularly performing tasks while working at a computer, desk, laboratory bench or automated machine. Work may involve occasional climbing or balance. Work entails occasional lifting and/or moving up to 25 pounds. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Ability to sit and/or stand for extended periods, perform repetitive motions, and use standard office and laboratory equipment, including computers, copiers, fax machines, and PDF scanners.
• Ability to lift and/or move up to 25 pounds as required.
• May be required to handle blood-borne pathogens and general laboratory reagents.