About This Role
This Clinical Laboratory Scientist I position involves performing clinical testing of patient samples, with a focus on molecular assays. The role requires adherence to quality control processes and meticulous documentation within a clinical laboratory setting.
Responsibilities
- Perform clinical testing of patient samples, including the set-up of molecular assays
- Adhere to the laboratory’s quality control processes and document quality control activities, instrument and equipment verifications, and instrument maintenance and preventive maintenance
- Support the Corporate and Laboratory Operations Goals and Objectives
- Follow the laboratory's policies and procedures whenever test systems are not within the laboratory's established performance specifications
- Identify and document problems that may adversely affect test performance and notify the manager or director
- Document all corrective actions taken when test systems deviate from the laboratory's established performance specifications
- Participate in activities required to support all necessary licensure for the clinical laboratory, including maintaining quality systems and test records and supporting on-site inspections of the laboratory
- Utilize an in-house Lab Information System (LIS)
- Comply with all local, state, and federal laws and regulations governing clinical laboratory operations
- Maintain records that demonstrate that proficiency testing samples are tested in the same manner as patient specimens
- Monitor the activities of non-licensed personnel (may be required)
- Assist in assay development activities (may be required)
- Perform other duties as assigned
Requirements
- Meet the requirements for Testing Personnel under CLIA 88 (42 CFR, part 493)
- Highly organized, able to work independently, and follow standard operating procedures
- Experience with manual and automative pipetting of patient samples and reagents
- Real-time PCR experience
- Experience manually pipetting reagents accurately to create master mixes for the assay
- Bachelor’s Degree in Medical Technology or Biological Sciences
- Clinical Genetics Molecular Biologist (CGMBS) or Generalist Clinical Laboratory Scientist (CLS) License from the State of California
Nice to have:
- Experience in a high complexity CLIA/CAP environment strongly preferred
- Experience in Molecular Biology, Molecular Pathology, and/or Medical Genetics preferred