Lead Laboratory Technologist

SUMMARY  

We are seeking a skilled and experienced Lead Laboratory Technologist to join our dynamic team and support the development of a new laboratory. As a key member of our team, you will play a pivotal role in establishing our laboratory operations, ensuring compliance with regulatory standards, and guiding the application process for Laboratory Developed Tests (LDTs) and FDA approval.  

This role includes leading daily laboratory activities, training staff, conducting competency assessments, and ensuring compliance and federal regulations, including Clinical Laboratory Improvement Amendments (CLIA). The Lead Laboratory Technologist will be instrumental in building our laboratory’s reputation for innovation and excellence. 

KEY RESPONSIBILITIES & DUTIES

• Assists with staff schedule preparation and workflow assignments as requested.   
• Assess competencies according to Clinical Laboratory Improvement Amendments (CLIA) and Florida State regulations. 
• Manages quality assessment and technical oversight, problem solving, scheduling, interviewing applicants, provides input for staff performance, oversees training and competency evaluations. 
• Assists the Laboratory management with special projects as assigned.  
• Reads, examines, and interprets complex test results. Serves as a resource and addresses complex tests/procedures. 
• Manages instrument maintenance and troubleshooting practices. 
• Leads quality control and quality assurance testing. 
• Assists with data collection and special projects, as assigned. 
• Performs assigned pre-analytical activities related to laboratory testing, which may include general and analytical equipment maintenance, function checks and documentation; inventory control and supply stocking, specimen collection as needed; biological specimen processing; cleaning and disinfection of selected or assigned laboratory equipment and spaces; quality control and calibration performance; and other pre-analytical activities. 
• Performs all expected tests and analytical procedures for assigned department or work area efficiently and accurately, according to established procedures, performance standards, and departmental competency standards. Participates in proficiency testing, consistently adhering to federal and state regulations as well as Institutional policies. 
• Performs post-analytical activities related to laboratory testing, reporting results (including highly abnormal results) in accordance with established procedures. Provides and acts on technical and support information related to the elements of laboratory testing for all age groups, neonatal through geriatric patients. 
• Provides orientation and training for new employees as needed, under the direction of the lab leadership. May act as a preceptor when teaching new staff. Appropriately documents orientation and training of new employees. 
• Provides guidance to technical and support staff, resolution to customer service issues within guidelines, and support education to clinical staff as appropriate or requested. Facilitates workflow when necessary. 
• Follows appropriate safety policies including the appropriate use of PPE, handwashing, and hazardous chemical handling. Demonstrates understanding and adheres to Chemical Hygiene plan.  
• Employee job duties may include transport of hazardous waste from the point of generation to a designated secure storage area. Employee will be required to complete initial training (prior to handling hazardous waste) and refresher training to include proper handling and transport of hazardous waste, and proper selection, use and disposal of personal protective equipment. 
• Participates in, and has knowledge of, laboratory and Performance Improvement activities. 
• Performs various support activities to facilitate operation of assigned department or work area. 
• Participates in the evaluation of new laboratory techniques and procedures. Assists with data collection and special projects, as assigned. Assists in the documentation and submission of required laboratory, departmental, and staff statistics/reports. 
• May perform Supervisor duties during extended absence of leadership to ensure the smooth operation of the department or work area. 
• Performs other duties as assigned.  

REQUIREMENTS/QUALIFICATIONS

• Education & Experience
  1. Bachelor’s Degree in the field of Laboratory Science or equivalent under the 1988 Clinical Laboratory Improvement Amendments (CLIA) guidelines of high complexity testing. 
  2. 6 or more years of technical experience is highly desirable.
  3. 2 or more years of leadership experience is highly desirable.
  4. Strong experience in chemical analysis techniques, such as calibrations and validations of new tests, using various chemistry analyzer platforms, is required.
  5. Expertise in molecular techniques and PCR testing is highly desirable.  
  6. Experience with LDT validation, FDA regulatory submissions, and navigating approval process is highly desirable.
  7. Experience with dried blood spot testing is highly desirable. 
• Licenses

• Certification from a recognized national body, such as the American Society of Clinical Pathologists (ASCP) or an equivalent organization is required.
• Florida Medical Technologist or Medical Technician license is required.  

• Skills/Abilities
  1. Knowledge of CLIA regulations regarding proficiency testing, quality assurance, and quality control. 
  2. Knowledge of laboratory policies and procedures. 
  3. Knowledge of laboratory equipment and testing. 
  4. Proficiency using computer programs and applications. 
  5. Proficiency operating a variety of laboratory support instrumentation. 
  6. Ability to establish and maintain positive relationships with employees, physicians, vendors, clients, and external agencies.  

WORK ENVIRONMENT 

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

PHYSICAL DEMANDS

External and internal applicants, as well as position incumbents who become disabled, must be able to perform the essential job specific functions (listed within each job specific responsibility) either unaided or with the assistance of a reasonable accommodation to be determined by the organization on a case-by-case basis. If the requirement is not marked, then the standard is generally considered not applicable.