Quality Assurance Manager

Regulatory Jobs; Houston (TX); Presencial; USD 90.000 - 130.000; Jornada completa

Descripción de la vacante

Regulatory Jobs in Houston, TX seeks a Quality Assurance Manager to lead, support and coordinate quality efforts across pre-analytical, analytical and post-analytical processes, aligned with company values and mission.

You will oversee licensing, accreditation (CAP, CLIA '88), proficiency testing and public health reporting, ensuring facilities and personnel maintain proper licensure and compliance, while driving QA/QI initiatives.

Formación

• Leadership and coordination of QA activities across pre-analytical, analytical and post-analytical processes.
• Strong understanding of CLIA regulations and CAP accreditation requirements.
• Experience with proficiency testing, public health reporting and quality improvement initiatives.

Responsabilidades

• Lead, support and coordinate QA activities ensuring consistency with company values.
• Direct internal inspection processes for compliance with federal, state and local regulations.
• Oversee proficiency testing enrollment and corrective actions for non-conformances.
• Manage Public Health Reporting compliance across the region.
• Implement and monitor Quality Management System plans across departments.

Conocimientos

Leadership

Regulatory knowledge

Quality management

Communication

Educación

Bachelor's degree in Medical Technology/Biology/C Chemistry

Master's in Biological Science (preferred)

CLIA '88 & CAP compliance knowledge (required)

Descripción del empleo

The Quality Assurance Manager will lead, support, and coordinate efforts that foster quality and ensure that all pre-analytical, analytical and post-analytical processes are consistent with our company values and mission. Oversees Quality Assurance activities and ensures RRL Quality Assurance compliance.

This position is based in Houston, TX.

• Leadership
  • Direct, advocate for and enable visibility of quality processes.
  • Ensure accountability within all areas of the business unit (pre-analytical, analytical and post-analytical) such that every employee consistently exhibits behavior that promotes and supports quality.
  • Influence may be exerted both directly and indirectly through the management of liaisons and intermediaries, such as department managers and supervisors as well as the Quality Assurance (QA) and Public Health Reporting staff.
• Licensing and Accreditation
  • Direct internal inspection process of the business unit, associated laboratories and specimen collection sites to ensure compliance with applicable federal, state, and local regulations, College of American Pathologists (CAP) accreditation requirements and Quest Diagnostics standards. Review and ensure that corrective action is implemented when non-conformances are found.
  • Monitor published guidelines for revisions to regulations and/or accreditation standards and ensure laboratory compliance. Serve as a resource regarding Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) regulations and CAP accreditation standards for all sites.
  • Ensure all testing facilities/personnel have appropriate licensure and accreditation as deemed by federal, state, and local regulations. Collaborate with business unit management even if primary responsibility has not been assigned to QA.
• Proficiency Testing
  • Identify all tests performed and ensure enrollment and participation in external proficiency testing for each test. For those tests not covered by external proficiency testing, ensure internal proficiency testing is performed. Ensure that all proficiency testing is reviewed, and corrective action is complete for all non-conformances.
• Public Health Reporting
  • Ensure that the Public Health System is in compliance with Public Health Reporting Laws of all the states within the region.
  • Manages the Public Health functions of the staff.
• Quality Assurance/Quality Improvement
  • Ensure that a defined instrument-to-instrument, method-to-method, and laboratory-to-laboratory comparison process, with fixed criteria for accessing acceptability, is performed and documented at least semi-annually.
  • Conduct monthly QA meetings with required participation by all areas (including RRLs) having an impact on pre-analytical, analytical and post-analytical phases of testing (exception Billing).
  • Ensure that each department has a comprehensive Quality Management System plan with monitors and that each department communicates their metrics and implements appropriate actions.
  • Develop, monitor and improve Quality Assurance specific quality indicators, including but not limited to: Reportable Quality Issues, Proficiency Testing outcomes, Revised Reports tracking, and performance on inspections.
  • Ensure all applicable employees are trained and comply with local quality policies. Ensure all QA policies have a biennial review.
  • Ensure a process is in place to resolve customer complaints regarding pre-analytical, analytical, and post- analytical issues.
  • Ensure performance of required Corporate Quality Inspection Program, Patient Results Distribution Program, Life Cycle Management Team Initiative/Database Changes Verification Program and other monitoring programs specifically assigned by Medical Operations and Quality (MOQ).
  • Ensure enrollment and participation in external federal and state cytology proficiency testing as well as required educational programs.
• Quality Control
  • Act as a contact for national Quality Control (QC) peer comparison programs and ensure enrollment and effective corrective action as appropriate.
• Quality Assurance Initiatives
  • Ensure all duties are appropriately delegated as required by applicable federal, state and local regulations.
  • Ensure that all departments have a process to identify and evaluate the relationship of patient information to patient test results. Ensure the process is in place, up to date, distributed and that all personnel are in compliance.
  • Ensure prompt and complete reporting Reportable Quality Issues in compliance with the Standard Operating Procedure (SOP) and ensure effective corrective action including issuance of revised reports as applicable.
  • Ensure complete tracking of revised reports in compliance with the SOP and ensure effective corrective action.
  • Ensure compliance with all Quest standards as required.

• Bachelor of Science in Medical Technology, Biology or Chemistry.
• Masters in Biological Science, or equivalent, is preferred.
• Certifications and qualifications, as General Laboratory Supervisor, as defined by CLIA '88 are required.
• Foreign educated candidates must provide a detailed credential evaluation from IERF (International Education Research Foundation).
• United States educated candidates must provide a detailed original transcript.

Work Experience:

• Minimum of six years clinical experience with two years participating in Quality Assurance initiatives or QA leadership roles.
• Direct or Indirect people leader experience is preferred.

Other:

• Must demonstrate effective communication and collaboration skills within department as well as with other functions within the company and third parties (ie., clients).
• Must have the ability to establish work priorities for self and others and handle several procedures simultaneously.
• Demonstrated success in motivating team members to reach objectives is highly desirable.
• Ability to schedule and manage resources to meet department goals.
• Must protect patient confidentiality at all times.