Clinical Lab Specialist II

Clinical Laboratory Specialist

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

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 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 and 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: <5%

Internal advancement statement

In order to be considered for advancement to the next CLS level, employees must possess the required qualifications, skills, and abilities as stated in the job description AND regularly demonstrate the qualities and behaviors commensurate with our CTS mission, vision, and values.