Job Description
Key Requirements and Duties:
The Clinical Laboratory Scientist I (CLS I) will perform analytical testing as well as general laboratory processes, in a high complexity clinical molecular laboratory in compliance with policies, procedures and regulations.
Responsibilities:
- Performs clinical testing of patient samples, which includes set-up of molecular assays.
- Adheres to the laboratory’s quality control processes and document quality control activities, instrument and equipment verifications, and instrument maintenance and preventive maintenance.
- Supports the Corporate and Laboratory Operations Goals and Objectives.
- Follows the laboratory's policies and procedures whenever test systems are not within the laboratory's established performance specifications.
- Identifies and documents problems that may adversely affect test performance and notifies the manager or director.
- Documents all corrective actions taken when test systems deviate from the laboratory's established performance specifications.
- Participates 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.
- Utilizes an in-house Lab Information System (LIS).
- Complies with all local, state, and federal laws and regulations governing clinical laboratory operations.
- Maintains records that demonstrate that proficiency testing samples are tested in the same manner as patient specimens.
- May be required to monitor the activities of non-licensed personnel.
- May be required to assist in assay development activities.
- Performs other duties as assigned.
Minimum Education/Experience Requirements:
- Clinical Genetics Molecular Biologist (CGMBS) or Generalist Clinical Laboratory Scientist (CLS) License from the State of California
- Bachelor’s Degree in Medical Technology or Biological Sciences.
- Must meet the requirements for Testing Personnel under CLIA 88 (42 CFR, part 493)
- Highly organized, able to work independently, follow standard operating procedures.
- Experience in a high complexity CLIA/CAP environment strongly preferred
- Experience in Molecular Biology, Molecular Pathology, and/or Medical Genetics preferred
Required Training/Certification:
• On the job training including, but not limited to: HIPAA, and safety procedures.