QA/QC Manager

QA/QC Manager

Irvine, CA, United States

About the Job QA/QC Manager

Quality Assurance Manager

About Us We are a licensed and accredited full-service medical reference laboratory with an extensive test menu of specialty assays. Our vision is to deliver information to our clinicians with accuracy, precision and speed so we have the most profound impact on the communities we serve. We are proud to deliver results you can trust, with some of the fastest turnaround times in the industry.

Job Summary The QA/QC Manager is responsible for oversight of the Quality Management System in its entirety. The QA/QC will ensure communication, training, competency assessment and ongoing compliance monitoring. The QA/QC will have access to personnel at all levels of the organization, as required.

Qualifications Masters Degree Preferred Prior laboratory experience required. Data entry/computer skills required. Ability to ensure communication, training, competency assessment, and ongoing compliance monitoring with all requirements of the laboratory's Quality Management System (QMS). Knowledge of accreditation regulations, CLIA and State laws regarding laboratory operations and billing and OSHA laws and regulations.

Responsibilities Oversee and evaluate the Quality Management System for adequacy and effectiveness. Serve as the resource person to the departments when there is a need for document review and compliance assessment. Provide ongoing compliance monitoring of all requirements of the Quality Management System. The coordinator acts as liaison among clients, operations, and especially quality assurance department to monitor and improve quality processes/workflow and efficient management of the technical procedures including patient test management and analytical testing in the lab environment. Responsible for communication between business-operation-QA, monitoring quality of operation, quality of pre-analytical, analytical and post-analytical phases including: Reagent quality, methods performance, quality control values to ensure quality of test results and correctness of reporting timely sample processing/testing/reporting of results, turn-around-time monitoring, client satisfaction related to testing results, attending to clients concerns/employees concerns and questions related to test results. Manage Quality Management System (QMS) which includes quality audits, quality metrics and monitoring of incident reports corrective action. Report to executive team the levels of quality achieved and identify those areas requiring improvement. Control of Documents and Records, and organization of records. Reliability of Measuring and Test Equipment. Complete corrective action/preventive action plans, as needed. Continuous improvement of quality and processes. Monitor or audit Customer Complaints. Perform Internal Audits.

Pay: $80,000 - $130,000 per year

Schedule: Full-time

Location: Irvine, CA