Clinical Lab Specialist II

Location: Maryland Heights

# ##
** 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), CLIA, and other applicable regulatory and accrediting bodies required.
* CLS Levels III and IV: + Must possess at least 1 year of clinical laboratory experience. + Must possess demonstrated advanced clinical laboratory knowledge and competency so as to provide testing quality control, as well as proficient training and guidance to newer staff. + Must possess demonstrated proficiency of complex equipment and reagent maintenance, for troubleshooting, and problem resolution. Advanced proficiency must be demonstrated with all equipment at the assigned location.

+ Must possess demonstrated understanding of, and experience with, proficiency survey sample testing.
* CLS Level IVs: + Must have previous experience as a Clinical Laboratory Specialist at Creative Testing Solutions. + Must possess demonstrated equipment calibration and qualification proficiency for all equipment at the assigned location. + Must possess advanced clinical laboratory competency expertise that meets regulatory and SOP requirements, so as to…