Quality Assurance Officer

TX-HHSC-DSHS-DFPS • Austin, TX

174d • Onsite

About The Position

Serves as a Quality Assurance (QA) Officer for highly advanced clinical testing laboratories: Coordinates and monitors assessments, evaluates documentation of clinical laboratory tests and procedures, and other QA activities within assigned clinical laboratories and associated laboratory support areas. Monitors, evaluates, and consults on the analysis of clinical samples using clinical biochemical genetics methods such as fluorometric, colorimetric, immunofluorometric, electrophoretic, molecular methods or other commonly used technology. Performs audits and reviews of Quality Management Systems, including technical areas to ensure adherence to certification/accreditation requirements for clinical laboratory procedures in hematology, chemistry and toxicology, clinical biochemical genetics, or molecular. Provides professional consultation and technical assistance to laboratory management, staff, public health personnel, regulatory officials, and external customers. Works under minimal supervision by the Quality Assurance Group Manager with considerable latitude for the use of initiative and independent judgment.

Requirements

• Knowledge of Federal or laboratory accreditation regulations (such as CLIA and CAP).
• Knowledge of clinical, diagnostic, and public health laboratory testing.
• Knowledge of laboratory information management systems.
• Knowledge of quality assurance.
• Knowledge of document management system requirements.
• Skill in applying problem solving techniques.
• Skill in use of personal computer for word processing and spreadsheet applications.
• Skill in resolving conflict.
• Ability to keep accurate detailed records.
• Ability to multi-task and manage multiple priorities.
• Ability to organize data and write detailed reports with recommendations.
• Ability to analyze complex scientific and regulatory information and reach an appropriate conclusion.
• Ability to interact positively with peers, subordinates and upper levels of management, and to build effective working relationships.
• Ability to work independently and make technical decisions based on review of data, professional knowledge and experience.
• Effective oral and written communication skills.
• Ability to manage projects.
• Ability to write standard operating procedures.
• At least 2 years experience testing patient samples in a high complexity CAP Accredited or CLIA Certified Laboratory.
• Have an earned bachelor’s, master’s, or doctoral degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution

Nice To Haves

• CAP Inspection Team Member Certification is preferred.

Responsibilities

• Serves as the QA Officer for assigned clinical testing laboratories within the Medical Screening Unit and associated support areas.
• Coordinates and monitors assessments, documentation, and other QA activities.
• Monitors, evaluates, and consults on the analysis of clinical samples using clinical biochemical genetics methods such as fluorometric, colorimetric, immunofluorometric, electrophoretic, molecular methods or other commonly used technology.
• Monitors proficiency testing (PT) programs, receives proficiency samples, initiates tracking forms, reports results and files PT records for easy retrieval.
• Reviews graded and ungraded proficiency survey evaluation reports and ensures that appropriate corrective actions are implemented and recorded.
• Annually reviews proficiency program participation to ensure regulatory compliance.
• Reviews new and revised standard operating procedures (SOPs) to ensure regulatory compliance.
• Reviews and verifies clinical laboratory reports for correctness and accuracy.
• Monitors annual review of procedures to ensure they meet periodic review deadlines.
• Reviews and approves Corrective Action and Preventive Action Requests; ensures actions are appropriate and monitors their effectiveness.
• Develops, implements, and reviews policies and procedures to ensure that quality systems are effective and that appropriate regulatory and certification/accreditation requirements are met.
• Consults federal publications such as the Federal Register (CFR), Clinical Laboratory Improvement Amendments (CLIA) documents, and College of American Pathologist (CAP) Checklists and confers with regulatory officials as needed.
• Leads QA meetings for assigned laboratories and ensures that quality issues or problems are addressed and corrected as appropriate.
• Performs audits and reviews of Quality Management Systems and processes to ensure adherence to certification/licensing requirements and laboratory policies and procedures.
• Performs audits of teams or areas within the laboratory in accordance with the Internal Audit Procedure or in response to requests from laboratory management to evaluate methods in hematology, chemistry and toxicology, clinical biochemical genetics, or molecular.
• Evaluates the performance of laboratory equipment and equipment documentation.
• Participates as CAP Inspection Team Member as required by CAP.
• Observes task performance and reviews records to determine practices in use, compares practices with standards established by regulatory agencies and internal policies, reaches conclusions about the nature and extent of non-conforming practices, prepares written audit reports, presents management briefings within specified time periods, and follows up to ensure implementation of corrective actions.
• Provides professional consultation and technical assistance to laboratory management, staff, public health personnel, regulatory officials, and external customers.
• Provides accurate, timely and professional responses to all inquiries or requests for assistance.
• Researches and interprets regulatory requirements and serves as a primary contact for regulating agencies.
• Provides guidance to management and staff in the development and implementation of new laboratory methods and procedures in hematology, chemistry and toxicology, clinical biochemical genetics, or molecular.
• Presents QA training to new and existing laboratory employees.
• Coordinates monthly QA meetings to communicate QA initiatives to technical staff and management.
• Assists with root cause analysis of non-conformances and development of corrective and preventive action plans.
• Ensures corrective actions are appropriate for the nonconformance.
• Monitors effectiveness of corrective actions and provides feedback as needed.
• Performs other duties as assigned.
• Actively participating and/or serving in a supporting role to meet the agency's obligations for disaster response and/or recovery or Continuity of Operations (COOP) activation.

Benefits

• Insurance coverage and other benefits available through the State of Texas Group Benefits Plan administered by the Employee Retirement System of Texas (ERS).

What This Job Offers

• Job Type: Full-time
• Career Level: Senior