Temporary CLIA Laboratory Quality Manager

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 Alzheimers 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 laboratorys successful implementation and ongoing operations.

Minimum Qualifications

Bachelors 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

• Bachelors degree in Medical Laboratory Science Biology Chemistry or related field
  (Masters preferred)
• ASCP certification (MT MLS or equivalent) and CAP accreditation strongly preferred
• 58 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 requirementsCLIA 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 relationshipsinternal 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.