Laboratory quality management consultant

Lighthouse Lab Services is seeking an experienced Laboratory Quality Management Consultant for a 12-week engagement with a healthcare system in Springfield, IL. The consultant will work closely with laboratory leadership to review the current Quality Management System (QMS), identify regulatory compliance gaps, and improve readiness for future College of American Pathologists (CAP) inspections and regulatory surveys.

About the Client

Our client is a community-based, nonprofit healthcare organization serving patients throughout central Illinois. Its Springfield hospital is an acute-care teaching hospital with a longstanding affiliation with Southern Illinois University School of Medicine. The laboratory supports a broad range of inpatient and outpatient testing and specialty services. This engagement will provide the opportunity to work directly with laboratory leadership to strengthen quality processes and support continued regulatory and accreditation readiness.

Project Goals

By the end of the 12-week engagement, the laboratory should have identified and addressed high-risk compliance gaps, established a clear CAP readiness plan, strengthened its internal quality processes, and implemented tools to support ongoing compliance.

Key Responsibilities

• Quality & Regulatory Assessment
  • Conduct a comprehensive review of the laboratory's Quality Management System.
  • Evaluate compliance with applicable CAP accreditation requirements and checklists.
  • Review compliance with CLIA, CMS, OSHA, and applicable state requirements.
  • Evaluate the laboratory's quality plan, quality indicators, management review process, document control, and occurrence reporting.
  • Review pre-analytic, analytic, and post-analytic processes.
  • Assess specimen management, test validation and verification, and equipment management.
  • Review personnel qualifications, competency assessments, training records, and continuing education documentation.
  • Evaluate proficiency testing and quality control processes.
  • Review nonconformance management and corrective and preventive action processes.
  • Identify regulatory risks and prioritize findings.
• Corrective Action & Process Improvement
  • Develop a prioritized corrective action plan based on identified gaps.
  • Assist laboratory leadership with corrective action implementation.
  • Review and revise quality documentation, policies, and procedures as needed.
  • Strengthen internal audit processes.
  • Standardize quality and regulatory documentation.
  • Improve occurrence management and root cause analysis processes.
  • Evaluate proficiency testing investigation practices.
  • Improve quality metric tracking and reporting.
  • Provide guidance to laboratory leadership and quality personnel on regulatory requirements and quality practices.
• CAP & Inspection Readiness
  • Conduct mock CAP inspections using applicable CAP checklists.
  • Evaluate the laboratory's overall inspection readiness.
  • Review evidence of corrective action implementation.
  • Confirm completion of identified action items.
  • Train laboratory leaders on ongoing compliance and inspection readiness.
  • Develop tools for continued compliance monitoring.
  • Establish processes to help maintain CAP accreditation readiness after the engagement is complete.

Project Deliverables

The consultant will be responsible for developing or supporting the following:

• Comprehensive Compliance Gap Assessment
• Regulatory Risk Assessment
• Priority Action Matrix
• CAP Compliance Improvement Plan
• Quality Management Program recommendations
• Corrective Action Tracking Tool
• Internal Audit Framework
• Mock CAP Inspection Findings Report
• CAP Readiness Assessment
• Final Regulatory Compliance Report
• Final Compliance Roadmap
• Sustainability and Monitoring Plan
• Executive Summary Presentation

Candidate Profile

Significant experience with laboratory quality management and regulatory compliance in a clinical laboratory setting. Strong knowledge of CAP accreditation requirements and inspection processes. Working knowledge of CLIA, CMS, OSHA, and applicable laboratory regulations. Experience conducting laboratory audits, gap assessments, and/or mock CAP inspections. Experience developing and implementing corrective action plans. Strong understanding of laboratory Quality Management Systems. Experience reviewing laboratory policies, competency programs, proficiency testing, quality control, and personnel documentation. Comfortable working directly with laboratory leadership and technical staff. Strong documentation and communication skills. Previous laboratory quality leadership or consulting experience preferred.

Schedule and Compensation:

Role will be hybrid with much of the work onsite but some remote. Pay rate is generous and based on background and experience.

About Us:

At Lighthouse Lab Services, we offer solutions to help start, grow, and run clinical laboratories. Our recruiting team has over 23 years of proven success placing job seekers in positions ranging from entry level Medical Technologists to seasoned Laboratory Directors. We recruit nationwide, for permanent and travel positions with clients ranging from small hospitals to large reference laboratories. It is the policy of Lighthouse Lab Services to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. Lighthouse Lab Services is committed to working and providing reasonable accommodation to individuals of all abilities, including persons with disabilities. If at any time during the application process, you need an accommodation, please contact recruiting@lighthouselabservices.com for assistance.

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