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Clinical Laboratory Specialist
2 months ago
Amerit Consulting is seeking an accomplished Clinical Laboratory Specialist to join our team. As a key member of our medical technology corporation, you will play a crucial role in the design, evaluation, and execution of safety and efficacy of new or modified in-vitro diagnostic devices.
Key Responsibilities- Provide input to design, evaluation, and execution of safety and efficacy of new or modified in-vitro diagnostic devices.
- Work with human blood in clinical laboratory disciplines such as phlebotomy, chemistry, hematology, coagulation, urinalysis, point of care, and capable operation of numerous instrument platforms.
- Manage clinical laboratory studies and complaint testing through various clinical testing methods.
- Develop and implement new testing methodologies in collaboration with R&D.
- Responsible for understanding product design, function, and applying quality and regulatory standards.
- Capable of performing Clinical Software Validations (CSV) and all requirements for new instrument validation/qualification as it relates to best practices for the IQ/OQ/PQ in the clinical lab.
- Utilize technical/scientific judgment to resolve technical issues.
- Work with various disciplines, materials, products, and processes in the development of core clinical laboratory and outside the core clinical laboratory products and services.
- Education: Bachelor's or Master's degree in Clinical Laboratory Science or Medical Technology, Biology, Life Sciences, or a related field.
- 5+ years of experience in the Clinical Laboratory environment.
- Strong working knowledge of clinical laboratory science.
- Excellent verbal and written communication skills.
- Awareness/basic knowledge of GCP/GLP and ISO regulations.
- Clinical Software Validations (CSV) and all requirements for new instrument validation/qualification as it relates to best practices for the IQ/OQ/PQ in the clinical lab.
- Phlebotomy is a plus.
- Experience with human blood specimen collection products.
- Product troubleshooting as it relates to clinical results.
- Strong computer skills.
- Strong project planning and budget management skills.
- Develop/implement new testing methodologies in collaboration with R&D.
- Proven understanding of clinical laboratory testing, blood collection, urinalysis, POC, and LIS/LIMS systems, and an ability to apply knowledge to innovative concepts/projects beyond the core clinical laboratory.
