Clinical Lab Specialist II

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.

PRIMARY DUTIES AND RESPONSIBILITIES

• 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

• 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.

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.

• 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 assist with staff competency assessments and training.

PREFERRED QUALIFICATIONS

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

SKILLS AND ABILITIES

• 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.

PHYSICAL & TRAVEL REQUIREMENTS

• 5+ hours per shift: Sitting, Standing Handling. Finger dexterity, Pinching.
• 3-5 hours per shift: Lifting to 40 pounds.
• Up to 3 hours per shift: Walking Climbing, bending, squatting, reaching above shoulders, reaching waist to shoulder, reaching knee to waist, reaching floor to knee, grasping items, carrying/move items up to 40 pounds.
• Travel: