Clinical Lab Scientist Technical Specialist

Sutter Health•Livermore, CA

49d•$73 - $103•Onsite

About The Position

Leads and actively participates in laboratory projects involving the implementation of new instrumentation, testing methodologies, assays, and laboratory services. Serves as a technical project resource from planning through implementation and go-live, including development and execution of validation and verification studies, evaluation of method performance, coordination of technical and LIS testing, review and analysis of validation data, preparation of required documentation, and resolution of technical issues. Collaborates with laboratory leadership, Technical and Medical Directors, Quality, LIS/IT teams, vendors, and other stakeholders to ensure new analyzers and tests are successfully validated, implemented, and integrated into laboratory operations. Supports project timelines, implementation readiness, staff training, procedure development, and post-implementation follow-up to ensure new testing meets quality, regulatory, operational, and patient-care requirements. Also functions as the technical and clinical subject matter expert in one or more areas of the laboratory. Duties routinely include evaluating Quality Control (QC) and Proficiency Testing (PT), taking corrective action when needed, as well as periodically summarizing QC and PT results in reports or graphs for Medical Director review. Also performs a variety of Quality Assurance (QA) duties such as review of records (patient testing, instrument maintenance, temperature, etc), taking corrective action when needed. Maintains up-to-date knowledge of technological advances and accreditation requirements related to assigned areas of the Laboratory. Plays a key role in maintaining accreditation readiness; participates in accreditation surveys and regulatory agency inspections. Advises on, and provides guidance for, technical and clinical problem-solving or troubleshooting, ensuring accurate and actionable test results. Advises on the technical aspects when new policies, procedures and protocols are being developed and implemented. Develops and coordinates the completion of validation and verification plans for new procedures and equipment. Develops training material and competence assessments for new procedures and equipment. Trains and assesses the competency of co-workers. Routinely performs all duties of a Clinical Laboratory Scientist, in one or more areas of the Laboratory. Adheres to all local/state/federal regulations, codes, policies and procedures to ensure patient privacy and maintain the highest level of safety and reliability in testing.

Requirements

Bachelor's degree in biological sciences or an equivalent major from an accredited college or university, completing the number of semester and/or quarter units in coursework relevant to a Clinical Lab Scientist Generalist license as specified by the California Code of Regulations – Title 17
CLSL-Licensed Clinical Lab Scientist
5 years recent relevant experience.
Demonstrated knowledge and technical competence in routine specimen collection, preparation, testing applications, laboratory operations, and quality assurance in one or more assigned clinical specialty areas; examples: Chemistry, Special Chemistry, Hematology/Coagulation, Urinalysis and Transfusion Service.
Demonstrates subject matter expertise in one or more technical areas of the Lab.
Knowledgeable as to regulatory and accreditation requirements.
Skilled in QC/QA, equipment troubleshooting, training, assessing competency, procedure development, and technical problem-solving.
Ability to organize and prioritize job duties and assigned tasks for completion within expected timeframes.
Ability to accurately, precisely, and reliably perform job duties and assigned tasks.
Demonstrates sound judgment and problem solving relevant to assigned duties.
Ability to compassionately and effectively interact with patients of diverse ages, backgrounds, values, beliefs and behaviors.
Workflow Management Ability to appropriately respond to: Fluctuations in volume, unexpected situations or problems such as equipment or information system failure, Shift-to-shift hand-offs, STAT test orders, Specimen integrity issues, Regular review of pending logs, and Priority assignments, etc.
Adherence to Practices & Procedures: Ability to follow standard practices, processes, and procedures in sequence.
Knowledge of applicable local/state/federal regulations, codes, policies, and procedures aimed at ensuring the privacy and safety of patients.

Responsibilities

Leads and actively participates in laboratory projects involving the implementation of new instrumentation, testing methodologies, assays, and laboratory services.
Serves as a technical project resource from planning through implementation and go-live, including development and execution of validation and verification studies, evaluation of method performance, coordination of technical and LIS testing, review and analysis of validation data, preparation of required documentation, and resolution of technical issues.
Collaborates with laboratory leadership, Technical and Medical Directors, Quality, LIS/IT teams, vendors, and other stakeholders to ensure new analyzers and tests are successfully validated, implemented, and integrated into laboratory operations.
Supports project timelines, implementation readiness, staff training, procedure development, and post-implementation follow-up to ensure new testing meets quality, regulatory, operational, and patient-care requirements.
Functions as the technical and clinical subject matter expert in one or more areas of the laboratory.
Evaluates Quality Control (QC) and Proficiency Testing (PT), taking corrective action when needed.
Periodically summarizes QC and PT results in reports or graphs for Medical Director review.
Performs a variety of Quality Assurance (QA) duties such as review of records (patient testing, instrument maintenance, temperature, etc), taking corrective action when needed.
Maintains up-to-date knowledge of technological advances and accreditation requirements related to assigned areas of the Laboratory.
Plays a key role in maintaining accreditation readiness; participates in accreditation surveys and regulatory agency inspections.
Advises on, and provides guidance for, technical and clinical problem-solving or troubleshooting, ensuring accurate and actionable test results.
Advises on the technical aspects when new policies, procedures and protocols are being developed and implemented.
Develops and coordinates the completion of validation and verification plans for new procedures and equipment.
Develops training material and competence assessments for new procedures and equipment.
Trains and assesses the competency of co-workers.
Routinely performs all duties of a Clinical Laboratory Scientist, in one or more areas of the Laboratory.
Adheres to all local/state/federal regulations, codes, policies and procedures to ensure patient privacy and maintain the highest level of safety and reliability in testing.