Manager, Quality Assurance

Quest Diagnostics•Seattle, WA

4d•Hybrid

About The Position

Lead, support and coordinate efforts that foster and establish laboratory quality and ensure that all pre-analytical, analytical and post-analytical processes are consistent with our company values and mission. This is a Hybrid position (3 days onsite, 2 days Work from Home) Pay Range: $93,000 - $140,000/ year Salary offers are based on a wide range of factors including relevant skills, training, experience, education, and, where applicable, certifications obtained. Market and organizational factors are also considered. Successful candidates may be eligible to receive annual performance bonus compensation.

Requirements

6 + years of experience in the laboratory including people management and quality assurance duties.
Bachelor’s Degree in a chemical, physical, biological, clinical laboratory science or medical technology program (Required)
MT ASCP certification is required (or similar).
Proficiency in computer operations and Microsoft suit of applications
Team management
Negotiation and influence as a leader
Problem solving and use of knowledge and logic to resolve complex issues

Nice To Haves

6 + years of experience in the laboratory including people management and 4 + years of direct responsibility for quality assurance, and/or quality control and/or quality program management
ASQ certification (preferred)
Qualification as General Laboratory Supervisor as defined by CLIA '88 (preferred)

Responsibilities

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 supervisors and members of the Quality Assurance (QA) Committee.
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 and Laboratory Instrumentation Validation: 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. Ensure that a Validity Check program is in place, as well as a Blind Samples resubmission program, if applicable. 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.
Quality Assurance/Quality Improvement: Quality Management: Conduct monthly QA meetings with required participation by all areas having an impact on pre-analytical, analytical and post-analytical phases of testing. Create effective materials (e. g., graphs, charts) to promote Quality Improvement (QI) and present plans and results at monthly meetings. Ensure that each department has a comprehensive Quality Improvement 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. Prepare, revise and distribute a QA Manual or Plan that includes local QA policies. Ensure all applicable employees are trained and comply with policies. Ensure all QA policies have annual review as required. 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).
Quality Control: 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. Ensure the process is in place, up to date, distributed and that all personnel are in compliance. Ensure prompt and complete reporting of 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 and other key metrics are in compliance with the SOP and ensure effective corrective action when necessary. Ensure compliance with all Quest MOQ/CAP, and CLIA standards as they apply to the lab operations.