Clinical Laboratory Leader

1 week ago


Irvine, California, United States Staffosaurus Full time
Job Overview

Position: Laboratory Director

About Staffosaurus

Staffosaurus is a fully licensed and accredited medical reference laboratory known for its extensive array of specialized tests. Our mission is to provide clinicians with reliable information swiftly and accurately, ensuring a significant positive impact on the communities we serve.

Role Summary

The Laboratory Director plays a pivotal role in the establishment and ongoing enhancement of the Quality Management System, delegating responsibilities to the Laboratory Management Team.

Key Responsibilities:

  • Ensure qualifications and responsibilities align with the complexity of testing as mandated by regulations.
  • Quality Control (QC): Implement mechanisms to guarantee the test process adheres to accuracy and precision standards.
  • Patient Test Management (PTM): Maintain a record-keeping system that ensures the positive identification and integrity of patient specimens from collection through testing and reporting.
  • Proficiency Testing (PT): Conduct external tests for accuracy at least biannually, or perform alternative assessments when external tests are unavailable.
  • Quality Assurance/Quality Assessment (QA): Develop an ongoing plan to monitor quality results and address any issues that arise.
  • COLA Accreditation: Uphold the standards required for laboratory accreditation and promptly notify relevant authorities of any significant changes or issues.

Experience Requirements:

Essential:
- Demonstrated leadership experience in a clinical laboratory environment
- Comprehensive understanding of molecular biology, CGMP, laboratory techniques, and FDA regulations
- Strong foundation in microbiology, histology, and scientific research
- Expertise in data collection and analysis methodologies

Preferred:
- Knowledge of advanced laboratory technologies and automation systems
- Experience in formulating and executing quality control protocols
- Awareness of emerging trends in clinical laboratory practices

Compensation: $130,000-$145,000

Employment Type: Full-time



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