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Clinical Laboratory Scientist
2 months ago
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
