Clinical Lab Specialist II

Creative Testing Solutions•St. Louis, MO

19h•Onsite

About The Position

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. This role involves performing all assigned duties in compliance with internal SOPs and external regulations, maintaining acceptable attendance and punctuality, and communicating with customers, vendors, and couriers to ensure quality service. The specialist will assure quality customer service, perform routine testing of biological samples, and notify appropriate personnel of any identified problems. Duties may include assisting with processing bio-waste, specimens, and micro-plates, maintaining accurate records and documentation, and ensuring donor, patient, and employee confidentiality. Document reviews, packing and shipping supplies/specimens, receiving and managing incoming supplies and reagents, and assisting with lot changes are also part of the responsibilities. The role requires preparing, labeling, verifying, and performing prequalification of reagents, ensuring appropriate supply and reagent levels, and operating equipment while monitoring for errors. Routine preventive maintenance on equipment and identification of equipment malfunctions are necessary, with appropriate notification for additional service. The specialist will resolve routine problems, escalate non-routine issues, assist with problem investigation, and participate in performance improvement teams and training programs. Maintaining the cleanliness of equipment and work areas, and adhering to safety guidelines are essential. Additional duties for higher CLS levels include serving as a resource for corrections and clarification, analyzing and resolving complex equipment or reagent problems, investigating deviations, recommending corrective actions, assisting with competency documentation and records management, coordinating workflow, reviewing proficiency survey sample testing, escalating issues to vendors, and providing mentorship.

Requirements

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.
Must possess the skills and abilities to successfully perform all assigned duties and responsibilities.
Must be able to maintain confidentiality.
Must have proficient computer skills.
Ability to work in a team environment and participate as an active team member.
Must be able to understand, follow, and give precise written and verbal instructions, and perform all activities safely.
Must be able to read and comprehend written procedures and instructions.
Lifting to 40 pounds
Carrying/move items up to 40 pounds

Nice To Haves

Trainer Certification preferred, but required for CLS IVs in Plasma Services.
Previous experience as a Clinical Laboratory Specialist at Creative Testing Solutions.
Demonstrated equipment calibration and qualification proficiency for all equipment at the assigned location.
Advanced clinical laboratory competency expertise that meets regulatory and SOP requirements, so as to assist with staff competency assessments and training.

Responsibilities

Performs all assigned duties in compliance with internal SOPs and external regulations.
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.
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.
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.
May provide occasional backup and support to CLS Leads.