The Journey Begins with you.
There’s quite a distance between wondering and knowing. And for patients waiting for answers to important health questions, it’s a road they want to travel as quickly as possible.
At Quest Diagnostics Incorporated, we understand urgency. But more than speed, we focus our energies on accuracy. Currently, we seek a Auditor, QA - Licensedin ourValencia, CA location.
Schedule: Monday – Friday, 9:30am – 6:30pm, Day shift
Full-time, 40 hours weekly
*Salary dependent upon experience*
REQ # 3773258
The incumbent reports to the Director or Manager of QA/Quality. This position’s primary responsibility is to perform audit activities that ensure that the company adheres to Clinical Studies standards as specified by the Clinical Trial sponsor. The Clinical Trials QA Auditor conducts periodic audits of every quality element of the company’s procedure system and conducts testing verification audits in accordance with established procedures, federal and state regulations. The incumbent is responsible for issuing reports on deficiencies, deviations and follow up with Correction and Preventative Action (CAPA) to ensure compliance of the company procedures and policies. This position requires extensive interaction with others at many organizational levels in a variety of departments. The audit role requires sensitivity and impartiality in interaction with those whose functions are being audited, accordingly, effective interpersonal skills are absolutely essential.
1. Schedules, performs, and tracks accurate and timely Quality Audits and Inspections for pre-analytic, analytic and post-analytic processes and documentation in accordance with governmental and company requirements.
2. Manages all aspects of Clinical Trials audits: For audits originating from Clinical Trials QA and Sponsors, is responsible for accompanying the inspectors, taking notes, providing copies of requested documents, attending debriefing sessions, informing appropriate management and completing documentation of audit closure and follow-up for all inspection findings.
3. Responsible for final release of all Clinical Trials QA audit reports via auditing documentation and ensure all specifications were met prior to distribution to the Clinical Trials Sponsor.
4. Prepares accurate and timely reports of all audit findings.
5. Performs analyses of audit findings to identify any trends among non-compliance items and defects.
6. Performs periodic inspections for compliance with CFR 42, Part 493 (CLIA).
7. Maintains accurate records of audit findings and activities.
8. Provides annual Clinical Trials training and competency
9. Performs any special projects as assigned.
1. BA/BS Degree or equivalent experience.
2. A current California state Clinical Laboratory Scientist license to perform laboratory testing.
1. Minimum of 3 years QA experience in Quality Auditing function.
1. Strong verbal and written communication skills.
2. Excellent interpersonal skills.
This position requires the person to have Clinical Laboratory Scientist license with 5 years experience in different area of the laboratory.
How To Apply
Please Log In or Register to Upload a Resume and complete the online Application. Because of the large number of applicants to job openings, Quest Diagnostics will only contact candidates to be interviewed
Quest Diagnostics has many career opportunities for individuals whose talent, initiative and dedication will complement our belief that the patient comes first and that values do matter. We work to earn our customers’ trust every day by providing the highest quality diagnostic information services in a professional, accessible and informative way. Our workforce is diverse and talented and believes in our vision: "Empowering Better Health with Diagnostic Insights."
[All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities.]
Quest Diagnostics is an Equal Opportunity Employer: Women / Minorities / Veterans / Disabled / Sexual Orientation / Gender Identity.