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Auditor QA - Licensed- Valencia, CA req39606

Company: Quest Diagnostics
Location: Cerritos
Posted on: March 15, 2020

Job Description:

Auditor QA - Licensed- Valencia, CA req39606

Auditor QA - Licensed- Valencia, California - Monday-Friday 10am to 630PM

Look for more than answers. Patients and Physicians rely on our diagnostic testing, information and services to help them make better healthcare decisions. These are often serious decisions with far reaching consequences, and require sensitivity, tact and a clear dedication to service. It's about providing clarity and hope.

You will work for the world leader in the industry, with a career where you can
expand your skills and knowledge. You'll have a role where you can act with
professionalism, you can inspire colleagues, and you can care about the work we do and the people we serve.

At Quest, we are on a continuous journey of discovery and development. It's this attitude that has made us an industry leader and the #1 Diagnostic Lab in the US. For those joining us, we offer exciting and fast moving career opportunities where you can affect change at a rate unheard of in many organizations of our size and scope. While we invest in and develop technology to drive our innovations, our ongoing success relies on our people.

JOB SUMMARY:

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.

JOB RESPONSIBILITIES:

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.

JOB REQUIREMENTS:

Education:
1. BA/BS Degree or equivalent experience.
2. A current California state Clinical Laboratory Scientist license to perform laboratory testing.

Work Experience:
1. Minimum of 3 years QA experience in Quality Auditing function. Special Requirements:
1. Strong verbal and written communication skills.
2. Excellent interpersonal skills.

"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 or Citizenship."

Keywords: Quest Diagnostics, Cerritos , Auditor QA - Licensed- Valencia, CA req39606, Accounting, Auditing , Cerritos, California

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