Clinical Laboratory Scientist

Genalyte•San Diego, CA

1d•$38 - $54

About The Position

The Clinical Laboratory Scientist will independently perform high-complexity clinical testing, support assay quality and instrument performance, and contribute to workflow optimization. This role also supports training, SOP development, assay validation, and cross-functional collaboration across QA, Data Management, Client Services, and Clinical Research.

Requirements

Active California CLS or CGMBS license (required)
Must possess a valid CA phlebotomy certification
Bachelor’s degree in a chemical, biological, physical, or clinical lab science (or qualifying equivalent).
Experience with high-complexity testing; molecular methods (PCR, microarray, Sanger/NGS) highly preferred.
Strong analytical, troubleshooting, and technological skills.
Excellent communication, teamwork, and adaptability in a fast-paced lab environment.
Ability to maintain required CE units for state licensure.
Proficient with Google Workspace

Nice To Haves

Experience working on medical device studies and/or in-vitro diagnostics studies preferred

Responsibilities

Perform hematology and clinical chemistry diagnostic testing in accordance with CLIA, SOPs, and quality management systems
Perform phlebotomy, collection and processing of patient samples by obtaining blood specimens through venipuncture and fingerstick
Maintains specimen integrity by using aseptic technique, following department procedures; observing isolation procedures
Document all QC activities, maintenance, calibrations, and corrective actions.
Troubleshoot routine and complex assay/instrument issues and serve as a subject matter expert
Lead process improvement initiatives, including workflow efficiency, TAT improvements, and cost-saving efforts
Participate in proficiency testing, regulatory inspection readiness, and quality committee initiatives
Support assay validation projects and contribute to development and revision of SOPs
Train and assess competencies of testing personnel and support expansion of laboratory capabilities
Meet milestones for product development timelines
Work as part of a multi-disciplinary team with other chemists, data scientists, engineers and manufacturing personnel
Maintain compliance with all company policies, quality systems, design control and procedures
Document results, protocols, SOPs, etc
Supports product improvement and manufacturing optimization
Perform review of clinical data listings for completeness and accuracy; and escalate issues to the Clinical Operations Manager/Study Lead as needed.
Proactively and effectively communicate the status of clinical studies to management.
Participate in the interim and final reviews of study data in preparation of regulatory submissions
May interact with RA/QA in responding to audits and FDA inquiries
Assist senior staff in development of study-specific forms and trial-specific monitoring plans