Clinical Lab Specialist II

# **Job Description Summary** Under direct supervision, a Clinical Laboratory Specialist (CLS) is responsible for performing routine high complexity testing of biological specimens. CLSs work in a team environment to ensure timely and quality test results. Clinical Laboratory Specialists must maintain required competencies for applicable testing. **Job Description** **PRIMARY DUTIES AND RESPONSIBILITIES** *Duties and responsibilities regularly performed by and assigned to CLS levels II, III, and IV:* - Performs all assigned duties in compliance with internal SOPs and external regulations. Brings compliance issues to the attention of management. - Maintains acceptable attendance and punctuality per the absence policy. - Communicates with customers, vendors, and couriers to ensure quality service. Assures quality customer service to all customers. - Performs routine testing of biological samples and notifies appropriate personnel of any identified problems. May assist with processing bio-waste, specimens, and micro-plates. - Maintains accurate records and documentation. Ensures donor, patient, and employee confidentiality. Performs document reviews as assigned. - May pack and ship supplies and/or specimens. May receive and manage incoming supplies and reagents. Assists with lot changes as directed. - Prepares, labels, verifies, and performs prequalification of reagents. Ensures supply and reagent levels are at the appropriate levels and notifies appropriate personnel when new supplies are needed. - Operates equipment and monitors for errors and responds appropriately. Performs routine preventive maintenance on equipment and identifies equipment malfunctions. Notifies appropriate personnel if additional service is needed. - Resolves routine problems and escalates non-routine issues when appropriate. Assists with problem investigation. - Participates in performance improvement teams and training programs, as required. - Maintains the cleanliness of equipment and work areas. Adheres to safety guidelines. - Performs all other duties, at the discretion of management, as assigned. *Additional duties and responsibilities regularly performed by and assigned to CLS levels III and IV:* - Serves as a resource for corrections and clarification. - As appropriately delegated laboratory leadership: - Analyzes, prioritizes, and resolves complex equipment or reagent problems. Investigates deviations in testing, quality control, and preventative maintenance. - Recommends and implements corrective actions. - Assists with competency documentation, records review, and records management. - Assists with workflow coordination. - Assists in reviewing results for proficiency survey sample testing. - Escalates applicable issues to vendors and ensures appropriate follow-up and resolution. - Provides mentorship and guidance to newer staff. *Additional duties and responsibilities regularly performed by and assigned to CLS level IVs:* - Trains newer staff. - Liaises with vendors and clients and provides direct customer service. - Performs equipment calibration and qualification. Identifies and repairs equipment malfunctions, performs trouble shooting, and notifies appropriate personnel if additional service is needed. - Assists in coordination and performance of evaluations (e.g., reagents, equipment, new testing methods). - Assists with performing required competency assessments as directed by laboratory leadership. - As assigned, may provide occasional backup and support to CLS Leads. **REQUIRED QUALIFICATIONS** - Education: Bachelor’s or higher degree in Biology or Chemistry required, or science related degree where education and training meet CFR 493.1489. - CLIA requirements for High Complexity Testing required. - California testing requirements where required by law or SOP. - Appropriate state licensure and/or certificate, where applicable, required. - Must possess High Complexity Testing competencies required by Standard Operating Procedures (SOPs),…