Quality Assurance Specialist – Clinical Trials-Seattle, WA req42057 in Seattle, WA at Quest Diagnostics

Date Posted: 8/21/2020

Job Snapshot

Job Description

Quality Assurance Associate – Clinical Trials

 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 by clients and assist with preparation of responses
Conduct inspections of processes and facilities on a periodic basis
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 Qualification of PhenoPath Vendors, as needed
Help prepare the Quality Management Program Annual reports
Review controlled documents (SOPs, forms, etc.)
Write, review and/or revise QA SOPs
To qualify, the ideal candidate will have the following:
5+ 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
Experience performing audits and inspections
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

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