RCI-BDX-4285 Clinical Laboratory Scientist / Medical Technologist (Hematology)

Job Description

Onsite

Calibration of equipment, generate data, read data, and analysis. Phlebotomy experience is a plus. Follow protocols and ensure proper sample handling. Add instrument experience from the list below

BS ASCP MT/MLT CLS Certification check if active 5 years experience

Hepatitis Vaccine required

Job summary:

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• This laboratory-based position will provide input to design, evaluation, execution and reporting for safety and efficacy of new or modified in-vitro diagnostic devices, as well as provide innovative ideas cross functionally with other business units.
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• Possess a technical competence and works with human blood in clinical laboratory disciplines such as phlebotomy, chemistry, hematology, coagulation, urinalysis, point of care and capable operation of numerous instrument platforms.
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• Responsible for managing clinical laboratory studies and complaint testing through a variety of clinical testing methods.
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• Knowledge and expertise demonstrating safety and efficacy of new or modified in-vitro diagnostic devices, as well provide innovative ideas outside of the core business. Develop/implement new testing methodologies in collaboration with R&D.
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• Responsible for understanding product design, function and able to apply quality and regulatory standards. Utilizes technical/scientific judgment to resolve technical issues.
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• Works with many different disciplines (manufacturing, marketing, quality, regulatory, etc.), materials, products and processes in the development of core clinical laboratory and outside the core clinical laboratory products and services.
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• Possesses a strong commitment to quality and continuous improvement.
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Primary duties, responsibilities & authorities:

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• Provides input to and conducts scientific investigations in areas of considerable scope and complexity. Explores, identifies and recommends solution, concepts and principles.
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• Adapts methodologies as needed for areas related to the core clinical laboratory.
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• Conducts clinical testing, maintains laboratory instrumentation/reagent test systems and inventory to strategically align with the priorities within the lab and business objectives.
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• Implements and documents Quality Assurance and Quality Control procedures as they pertain to instrumentation and methodology.
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• Conducts instrument verification per CLSI guidelines, assists with updates and preparation of procedures and instrument performance documentation in compliance with GLP and GCP.
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• Keeps current in the field of Clinical Laboratory Science through review of technical literature, participation in continuing education via webinars/symposia and or customer visits.
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• Senses and monitors trends in laboratory practices and utilizes this information to recommend new projects and influence ongoing projects.
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• Participates in development of the clinical strategy for all Client IDS- Specimen Management products and is responsible for generation of scientific and clinical information to support product conceptualization, feasibility and development.
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• Responsible for scientific integrity and clinical accuracy of all claims and communications made concerning specific PAS products globally.
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• Responsible for management of individual focused projects to complex projects involving multiple internal clinical studies/evaluations.
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• This position provides support from a base of clinical experience and knowledge to resolve customer complaints through clinical investigations.
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• This position will also provide support to guide and implement innovation, product development, clinical testing, manufacturing, and post market surveillance via interfacing with R&D and GCD to insure successful and timely completion of projects.
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Knowledge and skills:

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• Strong working knowledge of clinical laboratory science
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• Excellent verbal and written communications skills
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• Awareness/basic knowledge of GCP/GLP and ISO regulations
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• Phlebotomy is a plus
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• Experience with human blood specimen collection products
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• Product Trouble shooting as it relates to clinical results
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• Strong computer skills
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• Strong project planning and budget management skills
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• Develop/implement new testing methodologies in collaboration with R&D
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• 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.
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Education and experience:

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• BS/BA/MA in Clinical Laboratory Science or Medical Technology, Biology Life Sciences or health related field required.
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• MT/MLT CLS (ASCP) or equivalent experience in a Research environment
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• 5 years+ experience in the Clinical Laboratory environment.
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