Clinical Laboratory Quality Specialist

Description
Job Description

Monitors laboratory testing performed, and participates in the implementation and use of point-of-care devices and tests. Assesses, trains, and monitors staff; observes and evaluates the quality of the processes to ensure accurate, reliable and prompt reporting of results; assures regulatory and accreditation requirements are satisfied. Provides advisory services and ensures best practice standards.

Job Responsibility

• Establishes regular communication processes users and suppliers; schedules and visits ancillary sites for periodic quality audits; addresses staff compliance issues and provides follow-up for required corrective action in response to unacceptable testing techniques or results.


• Interprets and resolves arbitrary technical issues and applies expertise in equipment, methods, and quality assurance principles.


• Implements and trains for methods and procedures for testing, quality control and maintenance/troubleshooting of equipment; evaluates and validates related new procedures and instruments; maintains and reviews quality management programs to meet regulatory and accreditation requirements.


• Coordinates annual competency assessment and certification of staff.


• Assists with the evaluation of new test methodology and validates related new procedures and instruments; acts as a technical resource in the operation and maintenance of equipment used across all testing locations.


• Provides assistance for the procurement of equipment and supplies used in point of care testing; maintains an adequate inventory related supplies, and ensures products and supplies are stored in accordance with applicable requirements and are used prior to expiration; dispositions expired supplies.


• Maintains equipment and instrumentation, including verification of appropriate performance, calibration, linearity and correlation to laboratory methodology, as required; assists with troubleshooting problems with equipment and interacts with manufacturer/service engineers, when needed.


• Performs statistical analysis of daily work, with attention to cost containment, quality assurance and quality control; assesses testing sites to ensure a safe work environment; identifies and helps mitigate workplace hazards, including those related to biohazards and chemical hygiene practices.


• Schedules and administers the proficiency testing program, where applicable in compliance with regulatory requirements; ensures preparedness for audits/inspections and keeps informed of all state and federal regulations and applicable accreditation standards; provides requested records and documents to surveyors during audits and inspections.


• Performs related duties as required. All responsibilities noted here are considered essential functions of the job under the Americans with Disabilities Act. Duties not mentioned here, but considered related are not essential functions.

Job Qualification

• Bachelor's Degree required, or equivalent combination of education and related experience.


• Current License to practice as a Clinical Laboratory Technologist or Cytotechnologist in New York State preferred, plus specialized certifications as needed.


• 1-3 years of relevant experience, required.

*Additional Salary Detail


The salary range and/or hourly rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job advertisement and may be modified in the future.When determining a team member's base salary and/or rate, several factors may be considered as applicable (e.g., location, specialty, service line, years of relevant experience, education, credentials, negotiated contracts, budget and internal equity).