Clinical Laboratory Scientist

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This range is provided by Indotronix Avani Group. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$59.00/hr - $59.00/hr

Job Position:
Medical Laboratory Scientist

Duration: 12 months

Location:
Franklin Lakes, NJ 07417

Job Summary:

• 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. 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.
• Responsible for managing clinical laboratory studies and complaint testing through a variety of clinical testing methods. 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. Responsible for understanding product design, function and able to apply 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. Utilizes technical/scientific judgment to resolve technical issues. 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.
  
  Possesses a strong commitment to quality and continuous improvement.

Primary duties, responsibilities & authorities:

• Conducts clinical testing, maintains laboratory instrumentation/reagent test systems and inventory to strategically align with the priorities within the lab and business objectives.
• Conducts instrument verification per CLSI guidelines, assists with updates and preparation of procedures and instrument performance documentation in compliance with GLP and GCP.
• Responsible for scientific integrity and clinical accuracy of all claims and communications made concerning specific PAS products globally.
• Responsible for management of individual-focused projects to complex projects involving multiple internal clinical studies/evaluations.
• This position provides support from a base of clinical experience and knowledge to resolve customer complaints through clinical investigations.
• 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.

Knowledge and skills:

• Phlebotomy is a plus.
• Experience with human blood specimen collection products.
• Product Trouble shooting as it relates to clinical results.
• 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.

Education and experience:

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

• Associate

• Contract

• Research

• Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Biotechnology Research

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