What are the responsibilities and job description for the Temporary CLIA Laboratory Quality Manager position at University of North Texas Health Fort Worth?
Title:Temporary CLIA Laboratory Quality Manager
Employee Classification: Senior Compliance Officer
Campus: University of North Texas - Health Science Center
Division: HSC-Div of Rsrch & Innovation
SubDivision-Department: HSC-Health Institutes & Centers
Department: HSC-Inst Translational Research-304700
Job Location: Fort Worth
Salary: Commensurate with experience
FTE: 1.000000
Retirement Eligibility: TRS Eligible
About Us - Values Overview
Department Summary
The Institute for Translational Research is devoted to bringing novel diagnostics and interventions to patients and families suffering from neurodegenerative diseases, fostering translational research in neurodegenerative diseases at UNTHSC, and Create solutions for a healthier community. Our team spans basic "bench-top" science, clinical research, community-based research and clinical trials. Our translational approach is intended to foster discovery and expedite those discoveries toward the benefit of those suffering from brain disease. A particular emphasis of ITR is the development of personalized (or person-focused) medicine for Alzheimer's disease.
Position Overview
This temporary role will support laboratory preparation and CLIA certification while overseeing quality control and quality assurance processes, regulatory compliance, operational readiness, and laboratory documentation and reporting. These responsibilities are critical to ensuring compliance with CLIA regulations and institutional standards while supporting the laboratory's successful implementation and ongoing operations.
Minimum Qualifications
Bachelor's degree in healthcare administration, business, law or closely related field, and ten years of experience in healthcare, hospital and/or academic medicine, or any equivalent combination of education, experience and training.
Knowledge, Skills and Abilities
- Senior Leadership Skills
- Communication Skills
- Start up and built from scratch lab environment experience
- Strong Documentation Skills
Preferred Qualifications
- Bachelor's degree in Medical Laboratory Science, Biology, Chemistry, or related field
(Master's preferred) - ASCP certification (MT, MLS, or equivalent) and CAP accreditation strongly preferred
- 5-8 years of laboratory experience, with at least 2 years in a QC/QA or compliance focused role
- Direct experience with CLIA regulations and lab certification processes
Job Duties
- Design and implement all QMS policies, procedures, and daily checks.
- Investigate any errors, failures, or unexpected results and document corrective actions and preventative actions. Flag risks early, ensure every test meets federal and state regulations, proper documentation and response to all internal and external audits and report QC metrics and compliance status to leadership on a regular basis.
- Maintain QC and QA records that are audit-ready at all times, all regulatory requirements_CLIA, CAP, HIPAA, and applicable local and state regulations, build and maintain the QMS and Standard Operating Procedures (SOP).
- Lead the lab through the CLIA certification process from application to approval - (Essential)
- Serve as the primary point of contact for inspections (CLIA, CAP, state, federal) - (Essential)
- Manage proficiency testing programs and ensure timely submission, oversee daily lab workflows to ensure efficiency and accuracy.
- Monitor incidents/deviations, calibration records, maintenance logs, and vendor relationships,internal audits and continual quality improvement, environmental conditions, and reagent and supply inventory from a QA/QC perspective and environmental conditions, and reagent and supply inventory from a QA/QC perspective.
Physical Requirements
- Repeating motions that may include the wrists, hands and/or fingers.
- Sedentary work that primarily involves sitting/standing.
- Lifting and Moving objects up to 20 pounds.
- Communicating with others to exchange information.
Environmental Hazards
- Sedentary work that primarily involves sitting/standing.
Work Schedule
Monday - Friday 8a-5p On Site
Driving University Vehicle
No
Security Sensitive
This is a Security Sensitive Position.
Special Instructions
Applicants must submit a minimum of two professional references as part of their application. If needed, additional references can be added after the application has been submitted.
Benefits
For information regarding our Benefits, click here.
EEO Statement
The University of North Texas System is firmly committed to equal opportunity and does not permit -and takes actions to prevent - discrimination, harassment (including sexual violence, domestic violence, dating violence and stalking), and retaliation on the basis of race, color, religion, national origin, sex, age, disability, genetic information, or veteran status in its application, employment practices, and facilities; nor permits race, color, national origin, religion, age, disability, veteran status, or sex discrimination and harassment in its admissions processes, and educational programs and activities. UNT System Administration promptly investigates complaints of discrimination, harassment, and related retaliation and takes remedial action when appropriate. System Administration also takes actions to prevent retaliation against individuals who oppose any form of harassment or discriminatory practice, file a charge or report, or testify, assist, or participate in a related investigation or proceeding.
The University of North Texas System and its component institutions are committed to equal opportunity and comply with all applicable federal and state laws regarding nondiscrimination and affirmative action. The University of North Texas System and its component institutions do not discriminate on the basis of race, color, sex, sexual orientation, gender identity, gender expression, religion, national origin, age, disability, genetic information, or veteran status in its application and admission processes, educational programs and activities, and employment practices.