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IGeneX, Inc.
Part Time Clinical Pathologist Infectious Disease Diagnostics
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Job Description
We are seeking an experienced Clinical Pathologist to provide medical and scientific leadership for a high-complexity clinical laboratory specializing in infectious disease diagnostics. The ideal candidate will have a strong background in clinical pathology, clinical microbiology, infectious diseases, and laboratory medicine , with experience overseeing complex diagnostic testing in a regulated laboratory environment. This position will play a key role in maintaining and advancing the laboratory's testing programs, ensuring high standards of analytical and clinical quality, supporting regulatory and accreditation requirements, and collaborating with laboratory scientists, physicians, and other healthcare professionals. Key Responsibilities Provide clinical and scientific guidance regarding the development, validation, implementation, and interpretation of infectious-disease assays. Ensure compliance with applicable CLIA, CAP, state, and other regulatory requirements . Participate in regulatory and accreditation inspections and provide appropriate medical and scientific documentation. Review and approve laboratory procedures, validation studies, reference intervals, testing algorithms, and interpretive criteria. Collaborate with laboratory leadership and scientific staff on new test development and improvements to existing assays. Provide medical oversight for quality assurance, proficiency testing, competency assessment, corrective actions, and other laboratory quality activities. Help establish and maintain scientifically sound testing protocols and interpretation criteria. Qualifications Board certification in Clinical Pathology or Anatomic & Clinical Pathology . Eligible for or currently holding an appropriate medical license in the state where the laboratory operates. Experience in a high-complexity clinical laboratory environment. Strong knowledge of clinical laboratory medicine and diagnostic testing. Experience with laboratory quality systems and regulatory requirements. Excellent communication and collaboration skills.