Specialist, Quality Assurance III (CLS Licensed)

Quest Diagnostics•West Hills, CA

38d•Hybrid

About The Position

The Quality Assurance Specialist III is an expert, high-level quality advisor and subject matter expert responsible for the strategic governance of the Quality Management programs, risk management, and regulatory compliance within Quest Diagnostics. This senior-level specialist acts as a quality contact, coordinator for external and internal audits, and regulatory agency inquiries. The QA Specialist III leads root-cause analyses for quality occurrences, works with key individuals to execute root cause analysis, corrective action/preventive action plans (CAPAs) with remediation protocols, conducts system-wide gap analyses, and mentors other QA professionals to cultivate a robust culture of quality, safety, and compliance.

Requirements

8+ years of clinical lab experience, with 3+years in QA/compliance.
Excellent working knowledge of laboratory regulations and standards (i.e., CMS, CAP, CLIA) and the accreditation processes.
Strong working proficiency in Laboratory Information Systems (LIS).
Advanced proficiency in administering enterprise quality systems platforms
Proficiency in Microsoft Office applications (Word, Excel, Outlook, Teams)
Detail-oriented.
Strong organizational and prioritization skills.
Effective verbal, presentation and interpersonal communication skills; strong writing and composition skills required to draft executive reports and official agency correspondence.
Ability to track and closely monitor records management.
Proven leadership and consultation skills; ability to influence, guide, and collaborate effectively with Medical Directors, Lab Executives, and external clients.
Exceptional project management, analytical, problem-solving, change-management, and relationship-management skills.
Bachelor’s Degree in Medical Technology, Clinical Laboratory Science, Chemical, Physical, or Biological Science from an accredited institution.
Must meet CLIA '88 educational requirements for high-complexity testing.
Active California Clinical Laboratory Scientist (CLS) License (Generalist) or a California State Limited License in the applicable specialty is strictly required at the time of hire.
ASCP (American Society for Clinical Pathology) certification (MLS/MT) or an equivalent national certification is required.

Nice To Haves

5+ years of dedicated laboratory Quality Assurance experience, showing a progressive trajectory of responsibility and leadership.
Lean Six Sigma Green Belt training or experience is highly desirable.
May include people leader responsibilities (Non-Exempt QA Direct reports such as Dept QA Reps)

Responsibilities

Synthesizes complex quality indicators, audit outcomes, and compliance gaps into high-impact trend analyses and risk matrices.
Presents summaries and strategic plans to executive committees.
Governs and approves assigned performance reportables and other non-conformance follow-ups per policy.
Oversees inspection readiness schedules, reviews audits, and leads complex non-conformance audits.
Primary host/liaison for sponsor audits, partner evaluations, and major regulatory inspections.
Finalizes and directs Lab Director changes, biennial report approvals, and regulatory submissions.
Governs PT investigation processes and other laboratory compliance processes as assigned.
Directs, oversees, and finalizes investigations for systemic, critical, or large-scale quality events and RQIs.
Designs and executes patient-impact reviews, immediate remediation, and long-term CAPAs with effectiveness checks.
Delivers presentations; trains staff on accreditation-required processes and reviews systemic QI.
System-wide administrator for regional document control software; authors/approves general QA SOPs and rolls out SOPs system-wide.
Establishes systemic PT oversight, maintains the alternative proficiency testing list, reviews PT folders, and resolves complex inquiries.
Reviews technical validations/verifications and end-to-end testing.
Mentors other QA staff; designs QA training curricula and compliance metrics.
Supports government agency reporting as needed.
Other duties as assigned to meet business needs.
May provide oversight/lead other employees