Manager, Quality Assurance
About the role
Lead efforts that foster and establish laboratory quality, ensuring 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 all areas of the business unit (pre-analytical, analytical, and post-analytical) to promote and support quality.
Influence through management of liaisons and intermediaries, such as department supervisors and members of the Quality Assurance (QA) Committee.
Direct internal inspection process to ensure compliance with applicable regulations, CAP accreditation requirements, and Quest Diagnostics standards.
Review and implement corrective action for non-conformances found during inspections.
Monitor regulatory changes and ensure laboratory compliance.
Ensure all testing facilities and personnel have appropriate licenses and accreditations.
Collaborate with business unit management on quality matters.
Identify and enroll in external proficiency testing for all tests performed.
Ensure internal proficiency testing is conducted for tests not covered by external proficiency testing.
Implement and document a Validity Check program and a Blind Samples resubmission program, if applicable.
Conduct defined instrument to instrument, method to method, and laboratory to laboratory comparison processes at least semi-annually.
Conduct monthly QA meetings with required participation from all affected areas.
Create and present materials promoting Quality Improvement (QI).
Develop, monitor, and improve Quality Assurance specific quality indicators.
Prepare, revise, and distribute a QA Manual or Plan that includes local QA policies.
Train and ensure compliance with QA policies.
Resolve customer complaints regarding pre-analytical, analytical, and post-analytical issues.
Perform required Corporate Quality Surveillance Program, Patient Results Distribution Program, Best Practice Team Initiative/Database Changes Verification Program, and other monitoring programs.
Act as a contact for national Quality Control (QC) peer comparison programs and ensure enrollment and corrective action as needed.
Ensure all duties are delegated appropriately according to applicable regulations.
Evaluate the relationship of patient information to patient test results.
Report and correct reportable quality issues promptly and effectively.
Ensure complete tracking and reporting of revised reports and other key metrics.
Comply with Quest MOQ/CAP, and CLIA standards as they apply to lab operations.
Qualifications
6+ years of experience in the laboratory, including people management and quality assurance duties.
Preferred: 4+ years of direct responsibility for quality assurance, quality control, and quality program management.
Ability to sit for up to 8 hours working at a desk.
Ability to lift 15 or more pounds.
Ability to travel via automobile and aircraft.
Knowledge of laboratory operations, quality operations, and regulations (i.e., CAP, CLIA).
Proficiency in computer operations and Microsoft suite of applications.
Team management, negotiation, and influence skills as a leader.
Problem-solving and use of knowledge and logic to resolve complex issues.
Bachelor’s Degree in a chemical, physical, biological, clinical laboratory science, or medical technology program.
MT ASCP certification (or similar).
ASQ certification (preferred).
Qualification as General Laboratory Supervisor as defined by CLIA '88 (preferred).