Laboratory Operations and Quality Manager

Responsibilities

• Oversee daily laboratory operations, including specimen workflow, turnaround times, staffing coverage, and scheduling.
• Serve as the primary point of escalation for operational issues on the floor.
• Monitor and manage productivity, capacity, and workflow efficiency; adjust processes as volume grows.
• Coverage of specimen handling from receipt through reporting.
• Manage supply inventory, vendor relationships, and equipment maintenance schedules.
• Support laboratory expansion, relocation, and new-service initiatives as directed by the Laboratory Director.

Quality Management & Regulatory Compliance

• Develop, implement, and maintain the laboratory QMS.
• Ensure compliance with CLIA, CAP, OSHA, HIPAA, state, and other applicable regulatory requirements.
• Maintain continuous inspection readiness; coordinate accreditation activities and responses to findings.
• Manage document control — policies, procedures, forms, and quality records.
• Oversee occurrence reporting, root cause analysis, and corrective/preventive actions (CAPA) through completion.
• Track, trend, and report quality metrics to laboratory leadership.

Process Improvement & Validation

• Lead internal audits and process assessments; identify and execute improvement opportunities.
• Cookordination validation and verification studies for new instruments, equipment, assays, and software.
• Review quality control and proficiency testing data for compliance and performance.

People & Training

• Supervise designated laboratory personnel; support hiring, onboarding, and performance management in partnership with the Laboratory Operations Director.
• Monitor staff competency assessments and coordinate quality-related training.
• Promote a culture of accountability, patient safety, and continuous improvement.

Risk Management

• Conduct risk assessments for laboratory processes.
• Investigate quality incidents, complaints, and nonconformances; develop and monitor action plans.

Qualifications

• Education: Bachelor’s degree in Medical Laboratory Science, Histotechnology, Biology, Chemistry, or a related scientific field required; Master’s degree preferred.
• Certifications: HTL(ASCP) or HT(ASCP) preferred; MLS(ASCP), QIHC(ASCP), or CPHQ a plus.
• Experience: 5+ years of progressively responsible experience in a histology or anatomic pathology laboratory required. 2–3+ years of laboratory supervisory or management experience strongly preferred.
• Hands-on experience with CAP/CLIA compliance and laboratory inspection preparation required.

Knowledge, Skills & Abilities

• Deep knowledge of histology laboratory operations, workflow, and instrumentation.
• Strong command of laboratory quality systems, QA principles, and regulatory standards.
• Proven ability to lead teams, manage competing priorities, and drive change on the floor.
• Strong analytical, organizational, and communication skills.
• Proficiency with laboratory information systems (LIS) and Microsoft Office.