Quest Diagnostics · 2 days ago
Assoc, Quality Sr - Clinical Trials
Seattle, WA
Full-time
Onsite
Mid, Senior Level
$95K/yr - $130K/yr
4+ years expQuest Diagnostics is a leader in diagnostic information services, and they are seeking an Associate Quality Senior in Clinical Trials. This role involves conducting audits, ensuring compliance with regulatory requirements, and participating in the Quality Management Program to enhance quality assurance efforts.
BiotechnologyHealth CareHealth DiagnosticsInformation ServicesPrecision Medicine
Responsibilities
Initiate and conduct audits on a periodic basis according to an established schedule/annual audit plan, e.g. audits of study data/records and documentation, Facility inspections, Validation & Qualification etc
Prepare written reports of findings to Management as applicable
May act as facilitator/host for audits by clients. Assist with preparation of audit responses and follow-up to ensure remedial or corrective action resulting from audits is completed within the specified time frame
Participate in the Quality Management Program including, but not limited to: Document Review: Review SOP, Study Document Review for compliance with regulation requirements, Quest corporate policy, guidance documents and industry best practice, as applicable Non-conformances (NCEs), Corrective and Preventive Actions (CAPAs) and Complaints (Assist project and data management teams with Non-conformances (NCEs), Corrective and Preventive Actions (CAPAs) and Complaints
Participate in the development of annual audit and inspection plans; assist with preparation of quality plans & annual reports, as directed
Collect data as directed for KPIs and Metrics for Quality Assurance Function. Provide data to Manager/Senior Manager as directed to include in metrics reports. Assist in maintaining and monitoring Quality Assurance specific quality indicators
Assist project and data management teams with Non-conformances (NCEs), Corrective and Preventive Actions (CAPAs) and Complaints
Write, review and/or revise QA SOPs
May respond to requests for information (client questionnaires)
Training
Uphold and promote Quest Diagnostics Core Values
Qualification
Required
4-5 years' experience in a QA role in a GLP or GCP environment
Experience with US and international regulations related to clinical trials, e.g. EU clinical trial regulations
3-4 years prior experience in health-care related field, or at a Contract Research Organization or Central Lab
Knowledge and experience with FDA regulations (GCP)
Knowledge of 21 CFR Part 11
Knowledge of Good Clinical Laboratory Practice guidance
Knowledge of Quality Systems principles
Excellent verbal and written communication skills
Exceptional interpersonal skills
Strong influencing skills desirable
Demonstrated ability to manage multiple activities while maintaining a high level of organization
Strong organizational skills; detail oriented and a self-motivated problem solver
Ability to adapt to changing priorities
Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook
Bachelor's degree in a related scientific or technical discipline
Preferred
Experience with Quality Management Systems applications
Quality Assurance certification, e.g. RQAP-GCP, CQA preferred
Benefits
Medical/Prescription Drugs
Dental
Vision
Flexible Spending Accounts (FSAs)
Supplemental Health Plans
401(k) Plan – Company match dollar-for-dollar up to 5%
Employee Stock Purchase Plan (ESPP)
Supplemental Life Insurance
Dependent Life Insurance
Short- and Long-Term Disability buy-up
Blueprint for Wellness
Emotional Well-Being Resources
Educational Assistance
Paid time off / Health Time
Variable Compensation Plans
Sales Incentive Plans
Company
Quest Diagnostics
Quest Diagnostics is a clinical laboratory that offers diagnostic testing, services, and information.
10001+ employees
H1B Sponsorship
Quest Diagnostics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (59)
2024 (38)
2023 (74)
2022 (56)
2021 (49)
2020 (45)
Funding
Current Stage
Public CompanyTotal Funding
$2.6B2024-08-15Post Ipo Debt· $1.85B
2023-10-30Post Ipo Debt· $750M
1996-12-17IPO
Leadership Team
James Davis
Chief Executive Officer and President
Cecilia McKenney
SVP & Chief Human Resources Officer
Recent News
2026-01-09
Company data provided by crunchbase