Quest Diagnostics · 17 hours ago
QA/Compliance/Safety Specialist - CA
United States
Full-time
Remote
Mid Level
$97K/yr - $174K/yr
3+ years expQuest Diagnostics is a leading provider of diagnostic information services, and they are seeking a QA/Compliance/Safety Specialist to ensure that all Quality, Compliance and Safety activities in the region are accomplished. The role involves performing audits, ensuring compliance with procedures, and assisting in quality improvement projects.
BiotechnologyHealth CareHealth DiagnosticsInformation ServicesPrecision Medicine
Responsibilities
Act as the primary Patient Services auditor and perform audits per the current corporate schedule for all Patient Service Centers (PSCs) and In-Office-Phlebotomy (IOP) sites. Review audit results and corrective actions. Ensure timely completion of all corrective actions. Report audit status to supervisors, managers, regional and corporate Quality
Ensure that Patient Services is compliant with the current approved document control procedures. Review and update Patient Services’ procedures, policies and other controlled documents (PPDs) per current review requirements. Ensure all PPDs are current and aligned with testing laboratory, regional and national documents, and state or local regulations for Phlebotomy Scope of Practice. Ensure that all affected employees are trained before implementation of new and/or revised documents
Ensure that PSCs are prepared for internal and external regulatory inspections/audits. Work with the local QA Manager, Corporate Quality Mentor and Lab Director to implement corrective action and submit proper audit responses
Ensure that remedial actions are completed when issues are identified, and documented as required
Assist managers through the remedial process and ensure that all corrective actions, remedial actions and replication process are completed within a timely fashion
Review, analyze and prepare a monthly report for Problem Tracking/Customer Care database. Make recommendations for process improvement and error reduction
Monitor and review specimen labeling discrepancies/mismatches with supervisors weekly. Provide monthly report to Manager
Review and analyze the monthly corporate Recollection Report. Report data and trends to supervisors and manager. Make recommendations for process improvement and error reduction. Presents metrics at QA meetings and provides end-of-year summaries for the Annual Quality Management Plan Assessments
Direct/participate in Quality Improvement projects for PSCs. Identify areas in need of improvement and carry out process improvement projects
Ensure that all records are maintained as required in accordance with the organization’s Compliance policies and the various regulatory agencies including temperature monitoring, centrifuge maintenance, eyewash checks, fire extinguishers, etc
Create training modules and assist with staff training, as needed, as it relates to compliance and quality measures
Ensure employee competencies and job authorizations are completed per current approved procedures and documented for all pre and/or post analytical functions performed in the region
Liaison between local Patient Services and the Clinical Laboratory staff regarding technical issues, new processes, regulatory issues and process improvement. Attend meetings with technical and quality assurance staff
Liaison between the local Patient Services and corporate Patient Services. Communicate with corporate Patient Services when clarification is needed, make recommendations for changes and corrections as applicable. Review new procedures issued from corporate Patient Services for compliance with local regulations and suitability for local implementation. Work with the local Medical Director to revise, adapt and implement new procedures and revisions
Liaison with regional Environmental Health and Safety (EHS) to implement policies and protocols as needed. Ensure PSC Biohazard Waste Permits are renewed per local regulations
Liaison with regional Compliance Department to implement policies and protocols as needed. Provide required data and responses for compliance metrics and audits
Assist with the development and maintenance of the Quality Programs for the Patient Service Centers in coordination with the Director of Patient Services, local Quality Assurance team, the Laboratory Director and other stakeholders
Qualification
Required
Bachelor's degree
Current California Clinical Laboratory Scientist License (for California), Medical Technologist License or Medical Laboratory Scientist License
Minimum three years technical experience
Intermediate to advanced computer literacy plus excellent communication and written skills
Ability to identify problems, conduct investigations and analyze data, present resolutions and monitor solution effectivity
Ability to work with and lead cross-functional teams with a wide variety of education and expertise, such as local technical subject matter experts, senior leadership, supervisory groups, and front line employees
Ability to influence positive change and promote team collaboration
Effective training skills using a variety of modalities, such as lecture and hands-on methods
Preferred
Masters' degree
Previous Patient Services or Clinical Laboratory supervisory and/or Quality Assurance experience
American Society for Quality (ASQ) certification
Benefits
Day 1 Medical, supplemental health, dental & vision for FT employees who work 30+ hours
Best-in-class well-being programs
Annual, no-cost health assessment program Blueprint for Wellness®
HealthyMINDS mental health program
Vacation and Health/Flex Time
6 Holidays plus 1 "MyDay" off
FinFit financial coaching and services
401(k) pre-tax and/or Roth IRA with company match up to 5% after 12 months of service
Employee stock purchase plan
Life and disability insurance, plus buy-up option
Flexible Spending Accounts
Annual incentive plans
Matching gifts program
Education assistance through MyQuest for Education
Career advancement opportunities
And so much more!
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