Job Description

We are looking for talented Medical Laboratory Scientist to join our team. As a Medical Laboratory Scientist, you will be instrumental in advancing our diagnostic capabilities, particularly focusing on ELISA-like technologies. This role requires a dynamic individual ready to engage both in research development and CLIA laboratory settings, ensuring the highest quality of our Laboratory Developed Tests (LDTs).

Key Responsibilities:

• Lead the development refinement of SOPs across all laboratory processes.
• Spreadhead the laboratory quality management system, fostering a culture of continuous improvement.
• Oversee validation and verification studies for advanced diagnostic methods.
• Uphold stringent laboratory procedures, ensuring compliance with regulatory standards.
• Drive quality control initiatives, maintain rigorous documentation and adherence to policies.
• Execute instrument maintenance, calibration, and qualification with meticulous attention to detail.
• Analyze Quality Indicators and apply data-driven insights to enhance laboratory operations.
• Resolve complex laboratory issues, optimizing test performance and operational efficiency.
• Maintain clear and proactive communications with the organization, escalating concerns to the CLIA Director as needed.
• Manage inventory ensuring the laboratory is well-stocked with essential supplies and reagents.
• Support the laboratory’s regulation obligations, contributing to certification and accreditation efforts.
• Participate actively in regulatory and compliance audits, demonstrating a thorough understanding of accreditation requirements.

Minimum Qualifications:

• Qualification meeting CLIA High-Complexity Testing Personnel requirements
• Bachelor's Degree with MT or equivalent certification (ASCP); or Fifty-week military Medical Laboratory Procedures course and meet qualifications for military enlisted occupational specialty of "Medical Laboratory Specialist"; Registered Medical Technologists (M.T.) by the American Society for Clinical Pathology (ASCP) or other recognized certification agency of medical laboratory professionals preferred.
• 3+ years clinical laboratory experience in a CLIA High Complexity Testing Laboratory
• Proven track record in managing CLIA-certification and Accreditation such as audits from accrediting bodies like the College of American Pathologists (CAP).
• Proficient with Medical Testing Site registration and CLIA certification requirements in Washington State, or more generally with CAP Accreditation.
• Proficient with Laboratory Information Management Systems (LIMS) and data visualization tools.
• Excellent verbal and written communication skills with demonstrated success in leading a team.

Preferred Qualifications:

• Advanced research experience, particularly in LDT development and validation.
• Proficiency in ELISA-based test methods and a robust understanding of structural biology and analytical chemistry.
• Expertise in immunochemistry assays and familiarity with automation equipment.

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