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Clinical Lab Specialist II

4 months ago

Bedford, United States Creative Testing Solutions Full time
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
Wages start at $22.50 per hour

Shift Differentials for 2nd (12%), 3rd (20%) and weekend (8%) shifts

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 & 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: