Clinical Laboratory Scientist

Identifai Genetics; San Diego (CA); On-site; USD 34,000 - 52,000; Part time

Job summary

Identifai Genetics, Inc. is seeking a part-time Contractor CLS to accession specimens, enter data into LIS, and transfer material to a contracted sequencing facility in San Diego under chain of custody.

The role includes run QC on returned NGS data and performing CLS technical review before final sign-out by the Laboratory Director. As the laboratory expands, duties may include instrument onboarding, workflow development, SOP maintenance, and staff training while maintaining strict QC/QA and

Qualifications

• Valid California CLS license: Generalist (CLS) or CGMBS.
• BS/BA in Chemistry, Biology, Clinical Laboratory Science, or a related field.
• One year of experience as a technologist in a clinical laboratory.
• Experience with specimen accessioning and LIS data entry.
• Single- and multi-channel pipetting.
• Ability to work without direct supervision and manage own schedule.
• Ability to read, write, hear, and communicate in English to the degree necessary to perform the job.
• Ability to travel to pick up or deliver specimens on occasion.

Responsibilities

• Accessioning and LIS: Receive and inspect specimens; verify details; enter and verify data in LIS; label, aliquot, and store specimens per SOP.

Skills

LIS data entry

Pipetting

English communication

Independent work

Education

BS/BA in Chemistry, Biology, Clinical Laboratory Science, or related field

Tools

LIS software

SOP execution

Job description

Status: Contractor / Part-time; May convert to full-time work as volume increases

FLSA: Non-Exempt

Reports to: Laboratory Director (or designee)

POSITION SUMMARY

Accession specimens, enter them into the LIS, transfer them to a contracted sequencing facility in San Diego under chain of custody, perform run QC on returned NGS data per SOP, and perform CLS technical review and approval before cases go to the Laboratory Director for final sign-out. Resolve issues that surface at any step.

The laboratory is new and currently operates with limited on-site

instrumentation. The role may convert to full-time as volume increases, adding instrument onboarding and workflow development.

RESPONSIBILITIES

Accessioning and LIS

• - Receive and inspect specimens. Verify patient identity, test order, specimen type, collection date/time, and requisition completeness.
• - Determine specimen acceptability. Document rejections and resolve discrepancies with the ordering client.
• - Enter and verify demographics, orders, and specimen data in the LIS.
• - Label, aliquot, and store specimens per SOP. Document storage temperatures.

Specimen transfer and chain of custody

• - Package and ship specimens to the sequencing facility per SOP and applicable shipping regulations (UN3373 Category B, IATA/DOT).
• - Complete and retain chain of custody records: custody forms, manifests, courier handoffs, temperature monitoring, receipt confirmation.
• - Reconcile shipped versus received manifests with the sequencing facility.
• - Document discrepancies, delays, and transit excursions.
• - Transport, pick up, or deliver specimens when required.
• - Perform run-level and sample-level QC review of returned NGS data against acceptance criteria in the SOP.
• - Evaluate control performance. Document and elevate QC failures. Initiate repeat, re-extraction, or re-sequencing per procedure.
• - Investigate technical, sample-quality, and data-integrity issues. Document corrective action.

Technical review and approval

• - Perform CLS technical review and approval of cases: specimen integrity, QC acceptability, result completeness.
• - Route approved cases to the Laboratory Director for final review and sign-out.
• - Confirm and document critical or unexpected findings per SOP prior to release.
• - Release and report results per SOP.

Laboratory operations

• - Write, review, and revise SOPs.
• - Maintain QC, QA, competency, and proficiency testing records for CLIA, CAP, and California CDPH requirements.
• - Perform preventive maintenance, function checks, calibration, and troubleshooting on assigned instruments. Maintain instrument and maintenance logs.
• - Prepare, test, and evaluate new reagents, controls, and lots prior to use.
• - Train and supervise laboratory assistants and clerical personnel as permitted by California laboratory law.
• - Use required PPE. Follow laboratory safety procedures.

On conversion to full-time

• - Onboard, install, and validate new instrumentation.
• - Support assay validation, verification studies, and method comparison.
• - Develop and document workflows, LIS build, and interfaces.
• - Train incoming staff.

REQUIRED QUALIFICATIONS

• - Valid California Clinical Laboratory Scientist license: Generalist (CLS) or Clinical Genetic Molecular Biologist Scientist (CGMBS).
• - BS/BA in Chemistry, Biology, Clinical Laboratory Science, or a related scientific field.
• - One year of experience as a technologist in a clinical laboratory.
• - Experience with specimen accessioning and LIS data entry.
• - Single- and multi-channel pipetting.
• - Ability to work without direct supervision and manage own schedule.
• - Ability to read, write, hear, and communicate in English to the degree necessary to perform the job.
• - Ability to travel to pick up or deliver specimens on occasion.

PREFERRED QUALIFICATIONS

• - CGMBS license or molecular/genomics laboratory experience.
• - NGS experience: library preparation, run metrics, QC interpretation, or
• - IATA/DOT shipping certification and chain of custody experience.
• - SOP authoring; CAP or CLIA inspection experience; new laboratory setup.

WORKING CONDITIONS

• - This role is subject to a post-offer medical examination as a condition of employment
• - Work in a laboratory that receives biological specimens, which may include agents of infectious disease. The role carries a risk of infection. The laboratory operates at Biosafety Level 2 (BSL-2). PPE is provided and required at all times.
• - Standing, sitting, and repetitive fine-motor work for extended periods.
• - Lifting and carrying specimen containers and shipping coolers.
• - Local travel for specimen transfer and courier handoffs.

Organization: Identifai Genetics, Inc.

Employee Status: Contractor; May convert to full-time employee as volume