Clinical Lab Specialist II

Creative Testing Solutions

About The Position

Under direct supervision, the Clinical Laboratory Specialist (CLS) performs routine high-complexity testing of biological specimens as part of a team focused on timely, quality results. The CLS must maintain required competencies for applicable testing. The role performs assigned work in compliance with internal standard operating procedures (SOPs) and external regulations, maintains required attendance, and provides quality service when communicating with customers, vendors, and couriers. Duties include routine specimen testing, maintaining accurate and confidential records, handling supplies and reagents, operating and maintaining equipment, resolving routine issues, following safety requirements, and participating in training and performance improvement activities. Additional responsibilities are specified for CLS levels III and IV, and further responsibilities for CLS level IVs. These include advanced troubleshooting, workflow support, proficiency survey review, mentorship, staff training, equipment calibration and qualification, and supporting evaluations and competency assessments. The posting identifies a Tuesday–Saturday schedule from 7:00 a.m. to 5:30 p.m. Travel is less than 5%.

Requirements

Bachelor’s degree or higher in Biology or Chemistry, or a science-related degree with education and training meeting CFR 493.1489.
Meet CLIA requirements for high-complexity testing.
Meet California testing requirements where required by law or SOP.
Hold appropriate state licensure and/or certificate where applicable.
Possess high-complexity testing competencies required by SOPs, CLIA, and other applicable regulatory and accrediting bodies.
Possess the skills and abilities to perform assigned duties and responsibilities.
Maintain confidentiality and have proficient computer skills.
Work effectively as an active team member.
Understand, follow, and give precise written and verbal instructions, perform activities safely, and read and comprehend written procedures and instructions.
For CLS levels III and IV: at least one year of clinical laboratory experience; advanced clinical laboratory knowledge and competency for testing quality control, training, and guidance; proficiency in complex equipment and reagent maintenance, troubleshooting, and problem resolution; and experience with proficiency survey sample testing.
For CLS level IV: previous experience as a Clinical Laboratory Specialist at Creative Testing Solutions; demonstrated equipment calibration and qualification proficiency for all equipment at the assigned location; and advanced clinical laboratory competency expertise meeting regulatory and SOP requirements to assist with staff competency assessments and training.

Nice To Haves

Trainer Certification is preferred, but is required for CLS IVs in Plasma Services.

Responsibilities

Perform assigned duties in compliance with internal SOPs and external regulations, and bring compliance issues to management’s attention.
Maintain acceptable attendance and punctuality according to the absence policy.
Communicate with customers, vendors, and couriers to ensure quality service.
Perform routine testing of biological samples and notify appropriate personnel of identified problems.
May assist with processing bio-waste, specimens, and micro-plates.
Maintain accurate records and documentation; protect donor, patient, and employee confidentiality; and perform document reviews as assigned.
May pack and ship supplies or specimens, receive and manage incoming supplies and reagents, and assist with lot changes as directed.
Prepare, label, verify, and prequalify reagents; monitor supply and reagent levels and notify appropriate personnel when supplies are needed.
Operate equipment, monitor for errors, respond appropriately, perform routine preventive maintenance, identify malfunctions, and notify appropriate personnel if additional service is needed.
Resolve routine problems, escalate non-routine issues when appropriate, and assist with problem investigations.
Participate in performance improvement teams and training programs as required.
Maintain clean equipment and work areas and adhere to safety guidelines.
Perform other duties as assigned by management.
For CLS levels III and IV: serve as a resource for corrections and clarification; analyze and resolve complex equipment or reagent problems; investigate testing, quality control, and preventive maintenance deviations; recommend and implement corrective actions; assist with competency documentation and records management; assist with workflow coordination and review of proficiency survey results; escalate issues to vendors and follow through on resolution; and mentor newer staff.
For CLS level IV: train newer staff; liaise with vendors and clients and provide direct customer service; calibrate and qualify equipment; troubleshoot and repair equipment malfunctions; support evaluations of reagents, equipment, and new testing methods; assist with required competency assessments; and, as assigned, provide occasional backup and support to CLS Leads.