Manager, Quality Assurance

About the role

Lead efforts that foster quality and ensure all pre-analytical, analytical, and post-analytical processes align with company values and mission.

Responsibilities

• Direct, advocate for, and enable visibility of quality processes.
• Ensure accountability within the business unit (pre-analytical, analytical, and post-analytical) such that every employee consistently exhibits behavior that promotes and supports quality.
• Review and ensure 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 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.
• Identify all tests performed and ensure enrollment and participation in external proficiency testing for each test.
• Ensure that all proficiency testing is reviewed and corrective action is complete for all non-conformances.
• Ensure a Validity Check program is in place, as well as a Blind Samples resubmission program, if applicable.
• Ensure 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.
• Create effective materials (e.g., graphs, charts) to promote Quality Improvement (QI) and present plans and results at monthly meetings.
• 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.
• Prepare, revise, and distribute a QA Manual that includes local QA policies.
• Ensure all applicable employees are trained and comply with policies.
• Ensure all QA policies have annual 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 Surveillance Program, Patient Results Distribution Program, Best Practice Team Initiative/Database Changes Verification Program and other monitoring programs specifically assigned by National Quality Assurance (NQA).
• Ensure enrollment and participation in external federal and state cytology proficiency testing as well as required educational programs.
• Act as a contact for national Quality Control (QC) peer comparison programs and ensure enrollment and effective corrective action as appropriate.
• 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.

Qualifications

• Minimum 2 years Quality Assurance experience required.
• Minimum 5 years Quality Assurance experience preferred.
• American Society for Quality (ASQ) certification preferred.
• Bachelor’s Degree in Chemical, physical, biological or clinical laboratory science or medical technology.
• Qualification as General Laboratory Supervisor as defined by CLIA '88 (Preferred).