What are the responsibilities and job description for the Part-Time Laboratory Compliance Specialist position at Confidential?
Part-Time Laboratory Compliance Specialist
Reports to: Practice Administration
Schedule: 18 – 25 hours per month
Travel: Local travel required
Position Summary
The Part-Time Laboratory Compliance Specialist provides laboratory compliance and quality oversight for a private practice clinical laboratories. The employee conducts a scheduled monthly review at each of the practice's nine laboratory locations to evaluate quality control, required documentation, testing procedures, regulatory compliance, and inspection readiness. The position works collaboratively with Site Managers, laboratory staff, and Practice Administration to identify deficiencies, support corrective action, provide compliance guidance, and maintain readiness for regulatory and accreditation reviews.
Essential Duties and Responsibilities
· Visit each of the practice's locations once per month for approximately two hours per location.
· Review laboratory quality-control records, temperature logs, maintenance records, testing logs, and other required laboratory documentation.
· Verify that required quality-control testing has been performed, documented, reviewed, and maintained appropriately.
· Review out-of-range or failed quality-control documentation and verify that appropriate corrective action has been completed.
· Evaluate laboratory practices for consistency with established policies, manufacturer instructions, CLIA requirements, COLA standards, and other applicable requirements.
· Monitor proficiency-testing documentation and corrective actions, when applicable.
· Review laboratory equipment maintenance and required documentation.
· Identify missing, incomplete, inconsistent, or noncompliant laboratory records and communicate findings to the appropriate Site Manager and Practice Administration.
· Establish reasonable follow-up expectations and verify that identified deficiencies have been corrected.
· Assist with COLA inspection preparation and ongoing inspection readiness.
· Provide education, coaching, and compliance guidance to laboratory staff and Site Managers when deficiencies or training needs are identified.
· Review laboratory policies and procedures and recommend updates when standards, equipment, testing processes, or regulatory requirements change.
· Immediately escalate significant patient-safety concerns, repeated compliance failures, or serious regulatory deficiencies to Practice Administration.
· Prepare a concise monthly summary of completed site visits, findings, corrective actions, and outstanding compliance items.
· Perform other laboratory compliance-related duties as assigned.
Required Qualifications
· Current, active Florida Clinical Laboratory Technologist license issued by the Florida Department of Health and maintained in good standing.
· Clinical laboratory qualifications appropriate to the testing performed by the practice.
· Working knowledge of CLIA requirements, COLA standards, laboratory quality control, and required documentation.
· Experience reviewing laboratory records, identifying deficiencies, and implementing or monitoring corrective actions.
· Ability to work independently, organize monthly site reviews, and communicate findings clearly and professionally.
· Ability to travel independently among St. Petersburg Pediatrics' nine clinical locations.
Preferred Qualifications
· Prior experience with COLA-accredited or physician-office laboratories.
· Experience with laboratory inspections, compliance audits, quality assurance, staff competency, or laboratory education.
· Experience developing or reviewing laboratory policies, procedures, and corrective-action documentation.
Hours and Scheduling
The position is expected to work approximately 18 on-site hours per month, consisting of approximately two hours at each clinical locations. Additional paid working time may be required for documentation, follow-up, meetings, training, policy review, or inspection preparation. Monthly site visits will be coordinated in advance with Practice Administration. All time worked must be accurately recorded in accordance with practice policy.
Position Scope
This is a limited part-time laboratory compliance and oversight position. It is not a routine daily laboratory staffing position and is not intended to provide regular patient-testing or laboratory coverage.
Equal Employment Opportunity
Our practice is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, national origin, age, disability, genetic information, veteran status, or any other status protected by applicable law.
Work Location: In person