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.
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
Quality Assurance certification preferred; e.g. RQAP-GCP, CQA
Knowledge and experience in 21 CFR Part 11 is strongly preferred
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.