QA Coordinator

4 weeks ago

Irvine, United States Ultimate Staffing Full time

Happy Friday

We are also looking for a QA Coordinator for a lab department.

POSITION OVERVIEW (REGULATIONS)

1. 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.

2. Responsible for communication between business-operation-QA, monitoring quality of operation, quality of pre-analytical-post analytical phases including: Reagent quality, methods performance, quality control values with QA Manager/Director guidance 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.

DUTIES

1. Work as liaison among all departments and team members.

2. Manage completion of Quality Management System (QMS) which includes quality audits, quality metrics and monitoring of incident reports corrective action.

3. Report to executive team the levels of quality achieved and identify those areas requiring improvement.

4. Control of Documents and Records, and organization of records.

5. Reliability of Measuring and Test Equipment.

6. Corrective Action/Preventive Action.

7. Continuous improvement of quality and processes.

8. Monitor or audit Customer Complaints.

9. Perform Internal Audits.

10. Develop and deliver training programs that teach the appropriate use of quality tools at work.

11. Manage Quality Control Laboratory Analysts, test procedures, record and report of tests for assuring compliance with the applicable regulations.

12. Manage proficiency testing program.

13. Ensures that all testing on all shifts is completed and ensures that acceptable levels of analytic performance is maintained.

14. Assuring that all remedial actions are taken whenever test systems deviate from the laboratory's established performance specifications.

15. Annually document the performance of all departmental personnel.

16. Ensuring that patient test results are not reported until all corrective actions have been taken and the test system is functioning properly.

17. Ensure that policies and procedures are established, reviewed and signed off by the lab director, and all lab personnel have read and understood the content if applicable.

18. Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently.

19. Evaluating and documenting the performance of individuals responsible for testing at least semiannually during the first year the individual tests patient specimens. Thereafter, evaluations must be performed at least semiannually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation.

20. Ensuring Lab Director review for all new and/or revised procedures.

21. Ensures that QC is within appropriate limits and that all test results are accurate.

22. Assists work with vendors to bring new analyzers and/or methods on-line (if applicable).

23. Oversees quality of inventory.

24. Maintains the performance and recording of Proficiency Testing.

25. Assessment of the operation of all instruments in areas of responsibility and assigns maintenance procedures or repairs as needed.

26. Ensures that the records are organized, neat and readily retrievable.

27. Ensures that all specimens are organized and readily retrievable.

28. Ensures that the lab is organized, neat and clean.

29. Assigns duties as appropriate under State and Federal regulations to unlicensed personnel. (Calif. Business and Prof Codes section 1269.)


All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. To the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.

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