Clinical Lab Scientist Technical Specialist - Limited Term
About The Position
This is a one-year limited-term role, with the possibility of extension. The Clinical Lab Scientist Technical Specialist leads and participates in laboratory projects involving implementation of instrumentation, testing methodologies, assays, and laboratory services. The role provides technical project support from planning through go-live, including developing and executing validation and verification studies, evaluating method performance, coordinating technical and LIS testing, reviewing validation data, preparing documentation, and resolving technical issues. The specialist collaborates with laboratory leadership, Technical and Medical Directors, Quality, LIS/IT teams, vendors, and other stakeholders to ensure new analyzers and tests are validated, implemented, and integrated into laboratory operations. The position supports project timelines, implementation readiness, staff training, procedure development, and post-implementation follow-up to meet quality, regulatory, operational, and patient-care requirements. The specialist also serves as a technical and clinical subject matter expert in one or more laboratory areas. Duties include evaluating Quality Control (QC) and Proficiency Testing (PT), taking corrective action, summarizing QC and PT results for Medical Director review, and performing Quality Assurance (QA) reviews of records such as patient testing, instrument maintenance, and temperature logs. The role maintains knowledge of technological advances and accreditation requirements, supports accreditation readiness, participates in accreditation surveys and regulatory inspections, and advises on technical and clinical troubleshooting and procedure development. The specialist develops validation and verification plans, training materials, and competency assessments; trains and assesses co-workers; and routinely performs Clinical Laboratory Scientist duties in one or more laboratory areas. The role follows applicable local, state, and federal regulations, codes, policies, and procedures to protect patient privacy and maintain safe and reliable testing.
Requirements
- Bachelor's degree or higher in biological sciences or an equivalent major from an accredited college or university, including coursework meeting California Clinical Lab Scientist Generalist license requirements under Title 17.
- Licensed Clinical Lab Scientist (CLSL).
- Five years of recent relevant experience.
- Demonstrated knowledge and technical competence in specimen collection, preparation, testing applications, laboratory operations, and quality assurance in one or more clinical specialty areas.
- Subject matter expertise in one or more laboratory technical areas and knowledge of regulatory and accreditation requirements.
- Skills in QC/QA, equipment troubleshooting, training, competency assessment, procedure development, and technical problem-solving.
- Ability to organize and prioritize duties and tasks for completion within expected timeframes.
- Ability to perform duties and tasks accurately, precisely, and reliably.
- Sound judgment and problem-solving ability relevant to assigned duties.
- Ability to interact compassionately and effectively with patients of diverse ages, backgrounds, values, beliefs, and behaviors.
- Ability to manage workflow fluctuations, unexpected equipment or information-system problems, shift hand-offs, STAT test orders, specimen-integrity issues, pending logs, and priority assignments.
- Ability to follow standard practices, processes, and procedures in sequence.
- Knowledge of applicable local, state, and federal regulations, codes, policies, and procedures related to patient privacy and safety.
Responsibilities
- Lead and participate in projects implementing new laboratory instrumentation, testing methodologies, assays, and services.
- Develop and execute validation and verification studies, evaluate method performance, coordinate technical and LIS testing, review validation data, and prepare required documentation.
- Resolve technical issues and collaborate with laboratory leadership, Technical and Medical Directors, Quality, LIS/IT teams, vendors, and other stakeholders.
- Support project timelines, implementation readiness, staff training, procedure development, and post-implementation follow-up.
- Evaluate QC and PT results, take corrective action when needed, and periodically summarize results for Medical Director review.
- Perform QA duties, including reviewing patient-testing, instrument-maintenance, and temperature records and taking corrective action when needed.
- Maintain accreditation readiness and participate in accreditation surveys and regulatory inspections.
- Advise on technical and clinical troubleshooting and on the technical aspects of new policies, procedures, and protocols.
- Develop and coordinate validation and verification plans for new procedures and equipment.
- Develop training materials and competency assessments, and train and assess co-workers.
- Routinely perform Clinical Laboratory Scientist duties in one or more laboratory areas.
- Adhere to applicable regulations, codes, policies, and procedures to protect patient privacy and ensure safe, reliable testing.
Benefits
- Comprehensive benefits package for eligible positions.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
