Company Summary
Avellino Lab USA, Inc. is a pre-IPO world leader in genetic diagnostics and gene therapy research. Avellino developed the first commercially available genetic test for corneal dystrophy, providing a fast and accurate test to help guide physicians in treating their patients to prevent or delay vision loss. Avellino continues to innovate and has developed AvaGen, a next-generation sequencing (NGS) test for keratoconus. In addition to the diagnosis of these progressive eye diseases, Avellino is also developing state-of-the-art siRNA and CRISPR gene editing programs for corneal dystrophies and for treatment technologies that can be applied to other diseases beyond ophthalmology. Avellino operates globally and has been recognized for its work, including being named a Technology Pioneer by the World Economic Forum.
As of 2020, Avellino has an FDA-authorized coronavirus diagnostic test –the Avellino SARS-CoV-2/COVID-19 Test (“AvellinoCoV2”) – a Laboratory Developed Test (LDT) that uses Real-Time Reverse Transcriptase (RT)-PCR for the presumptive in vitro qualitative detection of nucleic acid from the SARS-CoV-2 virus. Avellino is ramping up operations in order to meet the worldwide need for coronavirus testing.
Position Summary
Under the direction of the Sr. Laboratory Operations Manager, performs pre-analytical, analytical and post-analytical procedures and analyses at Avellino Lab USA Inc. (Avellino) to provide high quality testing data. The CLS Supervisor is responsible for the day to day operation and administration of the Clinical Laboratory for a shift and maintains projects and other areas assigned in accordance with Federal Regulations governing clinical laboratories as delegated by the Laboratory Director.
Night shift - 11 pm - 7:30 am, Mon-Fri
Essential Functions
- Provides day-to-day supervision of testing personnel and reporting of test results for high complexity testing and is under the direction of the Laboratory Director and supervision of the Technical Supervisor.
- Must be accessible to the laboratory to provide on-site consultation to resolve operational problems in accordance with policies and procedures established either by the Laboratory Director or Technical Supervisor.
- Responsible for personnel scheduling and reviewing timesheets in a timely manner.
- Leads projects to support new instrumentation, process improvements, or other assignments as directed by Laboratory Management.
- Analyzes clinical laboratory specimen following standard methods and procedures.
- Judges the adequacy and qualities of specimens submitted for testing.
- Correctly verifies that the proper specimen is being analyzed for the appropriate patients and that the appropriate test is being performed.
- Performs quality control procedures to ensure accuracy of clinical data.
- Validates test results through correlation with test parameters and QC metrics.
- Confirms testing on all abnormal values to ensure accuracy prior to releasing of test results.
- Performs preventative maintenance and troubleshooting on instruments and equipment.
- Performs and documents instrument function by checking and calibrating specific lab instruments and documents data.
- Records on instrument logs any repairs, replacement, and maintenance needed of equipment.
- Adheres to the laboratory’s quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed.
- Follows the laboratory’s established non-conformance policies and procedures whenever test systems are not within the laboratory’s established acceptable levels of performance.
- Identifies issues that may adversely affect test performance or the reporting of test results and addresses the same.
- Documents all corrective actions taken when test systems deviate from the laboratory’s established performance specifications.
- Understands safety procedures relating to a laboratory to include handling of infectious biological agents as well as potentially hazardous chemicals; appropriate hazardous clean up procedures; universal precautions and infection control procedures.
- Trains laboratory assistants on proper techniques/procedures related to clinical laboratory practice.
- Performs other duties as necessary
Education and Experience
- Clinical Laboratory Scientist (CLS) license from the state of CA
- Have earned a master's degree in a chemical, physical, biological, or clinical laboratory science or medical technology from an accredited institution and have at least 6 years of laboratory training or experience or both in high complexity testing for the specialty of chemistry OR have earned a bachelor's degree in a chemical, physical, or biological science or medical technology from an accredited institution AND at least 6 years of laboratory training or experience or both in high complexity testing for the specialty of chemistry
- Command of Microsoft Office programs;
- Strong critical thinking and creative problem-solving skills; Advanced communication and interpersonal skills to develop and maintain effective relationships.
- Solid leadership and supervisory skills associated with planning work assignments, establishing priorities, scheduling instructional space, and ensuring completion of multiple projects.
- Ability to multitask in a dynamic work environment and prioritize competing deadlines
- Self-motivated, energetic, organized, and results oriented
Working Environment/Conditions
This job operates in a professional office environment and a clinical lab environment.
Must be able to climb stairs, be able to lift up to 20 pounds, regularly sit, speak and hear, and perform standing, stooping, twisting, and other physical movements. Reasonable accommodations will be made as necessary.