Quality Assurance Associate, GCP in Seattle, WA at Quest Diagnostics

Date Posted: 9/2/2019

Job Snapshot

Job Description

Look for more than answers.


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.

As a Quality Assurance Associate, you will work for the world leader in the industry, with a career where you will have the opportunity to collaborate and affect change while expanding your leadership skills and technical knowledge. You can make a real impact in a market that is growing and developing.

This professional will be based in our Seattle, WA. The selected candidate must be available for occasional domestic travel.

Quality Assurance Associate

The Quality Assurance Associate engages in planned and systematic activities to provide confidence that we are fulfilling our requirements for quality and continuous quality improvement. This professional conducts analysis to assess quality of care and participates in quality assurance studies. The Quality Assurance Associate recommends revisions to, or creation of, new protocols, policies, procedures and/or systems as a result of the analysis.

Job responsibilities:

  • Provide guidance to work teams to address quality requirements and improvement

  • Provide guidance on interpretation of regulatory requirements

  • Help maintain a state of “continual inspection readiness”, as well as specifically preparing for Vendor Qualification Audits, Regulatory Inspections, etc. 

  • Make recommendations for actions to close compliance gaps as appropriate

  • Assist with corrective action as appropriate

  • Participate in inspections and assist with preparation of responses

  • Conduct audits on a periodic basis according to an established schedule/annual audit plan

  • Prepare written audit reports of all activities and report findings as applicable

  • May assist with meeting preparation, minutes, etc., preparation and presentation of reports

  • Provide assistance with and review of NCEs and CAPAs

  • Assist in maintaining and monitoring Quality Assurance specific quality indicators

  • Assist in the prompt and complete reporting of Reportable Quality Issues (RQI)

  • Participate in administrative functions of the QAU (e.g. updating records, maintaining spreadsheets, preparation of reports, filing, etc.)

  • Assist with Vendor Qualification activities

  • Help prepare the Quality Management Program Annual reports

  • Review controlled documents (SOPs, forms, etc.)

  • Write, review and/or revise QA SOPs

  • Assist the Document Control System (ZenQMS) Manager: troubleshoot issues, assist and advise staff

  • May train staff on various topics

To qualify, the ideal candidate will have the following:

  • 3+ years of hands-on experience in a QA function

  • 3+ years of employment in a laboratory setting

  • Strong knowledge of GCP and/or GLP, Standard Operating Procedures, Document Control, and Quality Systems principles

  • Demonstrated knowledge of QA regulations and best practices

  • Excellent verbal and written communication skills; strong interpersonal skills, and a demonstrated ability to manage multiple activities while maintaining a high level of organization

  • Proficiency with Microsoft Office Suite; ability to utilize Excel for data analyses and production of charts and tables, including pivot tables; production of reports in Word, PowerPoint, etc., incorporating text and graphics

  • Ability to travel, as needed

  • Bachelor's degree in a related scientific or technical discipline, or equivalent

In addition:

  • Quality Assurance certification preferred; e.g. RQAP-GCP, CQA

  • Knowledge and experience in 21 CFR Part 11 is strongly preferred

Apply Today

Join us for competitive benefits and development opportunities in a progressive and supportive environment. Help us improve our service, and the experiences of our patients and colleagues. Work with us and together we can be better.

Your Quest career. Seek it out.

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.

If you’re interested in career opportunities, but not ready to apply, join our talent network to stay connected to us and receive updates on the latest job opportunities and company news.

Group of people