Specialist, Quality Assurance III; CLS Licensed

Job Description

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.

Work Schedule:

Hybrid (3 days onsite/ 2 days work from Home)

Pay Range: $115,000 - $130,000/ year, 5% Bonus

Salary offers are based on a wide range of factors including relevant skills, training, experience, education, and, where applicable, certifications obtained. Market and organizational factors are also considered. Successful candidates may be eligible to receive annual performance bonus compensation.

Benefits Information:

We are proud to offer best-in-class benefits and programs to support employees and their families in living healthy, happy lives. Our pay and benefit plans have been designed to promote employee health in all respects – physical, financial, and developmental. Depending on whether it is a part-time or full-time position, some of the benefits offered may include:

• 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

• 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.
  
  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. This is not an exhaustive list of all duties and responsibilities, but rather a general description of work performed by the position.
• May provide oversight/lead other employees

Required Work
Experience:

8+ years of clinical lab experience, with 3+years in QA/compliance.

Preferred

Work Experience:

5+ years of dedicated laboratory Quality Assurance experience, showing a progressive trajectory of responsibility and leadership.

Physical and Mental Requirements:

Primarily an office-based position requiring extensive screen time, report generation, and meeting…