Medical Laboratory Scientist
Medical Laboratory Scientist
Skills Alliance
Seattle, WA
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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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Seniority level
Associate -
Employment type
Full-time -
Job function
Science, Research, and Quality Assurance -
Industries
Biotechnology Research
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Medical insurance -
Dental insurance -
Vision insurance
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