Clinical Laboratory Technologist

Company: Staff Icons
Location: Plymouth
Posted on: March 20, 2023

Job Description:

QUALIFIED CANDIDATES MUST POSSESS MINIMUM OF B.S. DEGREE WITH MAJOR IN A SCIENCE-RELATED FIELD, PRIOR LC/MS/MS (MASS SPECTROMETER) EXPERIENCE (INCLUDING DATA INTERPRETATION); AND TWO YEARS OF PRIOR EXPERIENCE IN A CLIA LAB. PHARMACOGENOMICS OR PHARMACOMETABOLOMICS EXPERIENCE IS ALSO REQUIRED.

JOB DESCRIPTION
As a full-time Laboratory Technologist, you will participate in the day-to-day clinical laboratory operation and R&D projects, as assigned and in accordance with applicable CLIA regulations, GCLP for R&D (FDA), DEA, HIPAA, Standard Operating Procedures, and best practices. This position will operationally report to the Laboratory Director. The Lab Director and Lab Technologist will both be responsible for validating and executing commercial and research tests daily.

RESPONSIBILITIES
Operations General :
At direction of CLIA Lab Director:

• 
  
• Conduct pre-analytical, analytical, and post-analytical phases of clinical laboratory testing.
  
• Per the SOPs, perform test methods as required to obtain accurate and reliable results
  
• Verify test result reports including pertinent information required for interpretation.
  
• Ensure that the laboratory and environmental conditions are appropriate for the testing performed and provide a safe environment, free of physical, chemical, and biological hazards
  
• Verify that all self-completed duties are properly performed.
  
• To process specimens
  
• Perform test procedures.
  
• Report test results promptly and proficiently
  
• Ensure that PT samples are tested in the same manner as patient samples.
  
• Ensure that PT samples are tested in compliance with regulations that prohibit referral of specimens and sharing of or communication about results.
  
• Ensure that PT results are reviewed by the appropriate staff, and the corrective action plan is followed when PT results are found to be unsatisfactory
  
• Ensure that corrective actions are taken and documented, whenever significant deviations from the laboratory's established performance characteristics are identified, and patient test results are reported only when the system is functioning properly
  
• Ensure that patient test results are not reported until all corrective actions have been taken and the test system is properly functioning.
  
• Integrate post-analytics with report generator to ensure reporting of laboratory results to clinicians, either via portal or other channels
  
  Regulatory & Compliance :
  With support from Lab Director:
  
  
  • 
    
  • Ensure adherence to CLIA regulations and ensure new/continued licensing in all 50 states, and in accordance with Federal Code of Regulations
    
  • Ensure adherence to applicable safety regulations and ensure adequate testing environment.
    
  • Ensure compliance with laboratory SOPs for regulatory and operational requirements.
    
  • Ensure compliance with all HIPAA regulations.
    
  • As directed, participate in revision of internal laboratory SOPs for regulatory and operational requirements
    
  • As directed, participate in Quality Assessment (QA) and Quality Control (QC) Programs for production and R&D
    
    Research & Development :
    
    
    • 
      
    • As directed, assist in expanding, combining or reducing existing validated tests/assays
      
    • As directed, assist in creating new tests based on existing technology
      
    • Assist in the development and validation of new technologies via pilot and clinical analysis
      
      Communication :
      
      
      • 
        
      • Support Lab Director in interfacing with external clinicians in reporting of laboratory results
        
      • Communicate internally with Lab Director, in addition to other Corporation functions, including Operations, Data-Bioinformatics and Commercialization in optimizing operations, processes and growth.
        
        
        EDUCATION, KNOWLEDGE, SKILLS, & EXPERIENCE
        
        
        • 
          
        • Bachelors of Science degree required (ideally in Science)
          
        • Pharmacogenomics or pharmacometabolomics experience is required.
          
        • Prefer candidate who has successfully graduated from a National Accrediting Agency for Clinical Laboratory Science (NAACLS) or ASCP, accredited Medical Technology/Clinical Laboratory Science program or Successful graduation from a NAACLS or ASCP program
          
        • 2-years' experience in a CLIA lab required
          
        • Ability and experience running a mass spectrometer designed for LC/MS/MS analyses required.
          
        • Experience implementing commercial LDTs in a CLIA environment.
          
        • Beneficial to have experience validating and executing new tests and R&D projects in the laboratory setting
          
          

Keywords: Staff Icons, Detroit , Clinical Laboratory Technologist, Healthcare , Plymouth, Michigan