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Clinical Laboratory Scientist

2 months ago


San Diego, United States Amelia Canty Consulting Full time

Join the Clinical Laboratory team at AmprionDx, an emerging diagnostic leader, offering proprietary biomarker testing for neurodegenerative diseases. Responsible for pre-analytical, analytical, and

post-analytical processes associated with specimen processing, test performance and test result

reporting


This position requires a CLS Generalist License


Duties and Responsibilities:

  • Follow the laboratory’s procedures for specimen handling, labeling, processing, transportation, and storage
  • Responsible for monitoring test performance and specimen examinations to ensure that acceptable levels of analytic performance are maintained
  • Adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed
  • Follow the laboratory's established policies and procedures whenever test systems are not within the laboratory's established acceptable levels of performance
  • Document all corrective actions taken when test systems deviate from the laboratory's established performance specifications
  • Open shipping packages containing human medical specimens
  • Preparation, testing/qualification, and storage of reagents
  • Accurate transcription of handwritten and printed documentation onto worksheets and into laboratory information systems
  • Review, develop and/or author SOP’s and other regulatory documentation
  • Assist in the training of new personnel
  • Assist in the development of new clinical tests
  • May transmit patient results to clients
  • May participate in the performance review process for others
  • Attend and participate in intra and interdepartmental meetings, as required
  • Function as laboratory point person for incoming R/D or pharma projects
  • Maintain records that demonstrate that proficiency testing samples are tested in the same manner as patient specimens
  • Ensuring that patient test results are not reported until all corrective actions have been taken and the test system is properly functioning
  • Perform all duties in keeping with the company’s core values, policies, and all applicable regulations
  • Other duties may be assigned


Job Related Experience and Qualifications:

  • Required: CLS Generalist License; Minimum of two (2) years of laboratory experience in high complexity testing; excellent communication/interpersonal skills/problem-solving; highly organized and detail oriented; self-directed and accountable; CAP & CLIA laboratory experience


Preferred:

  • Ideally 3-4 years laboratory experience; experience with assay development and validation processes; NYS & FDA experience