Clinical Lab Specialist

3 days ago

Franklin Lakes, New Jersey, United States millenniumsoft Full time $80,000 - $120,000 per year

Position : Clinical Lab Specialist (No Microbiology, No Covid testers, No Chemical lab)

Location : Franklin Lakes, NJ

Duration : 12 Months

Total Hours/week : 40.00

1st Shift

Client: Medical Device Company

Job Category: Healthcare

Level Of Experience: Mid-Level

Employment Type: Contract on W2 (Need US Citizens or GC Holders Only)

Job Description:

  • 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:

  • Provides input to and conducts scientific investigations in areas of considerable scope and complexity. Explores, identifies, and recommends solution, concepts and principles.
  • Adapts methodologies as needed for areas related to the core clinical laboratory.
  • Conducts clinical testing, maintains laboratory instrumentation/reagent test systems and inventory to strategically align with the priorities within the lab and business objectives.
  • Implements and documents Quality Assurance and Quality Control procedures as they pertain to instrumentation and methodology.
  • Conducts instrument verification per CLSI guidelines, assists with updates and preparation of procedures and instrument performance documentation in compliance with GLP and GCP.
  • Performs 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.
  • 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.
  • Trains new associates (permanent or temporary) on the Laboratory workflow.
  • Senses and monitors trends in laboratory practice and utilizes this information to recommend new projects and influence ongoing projects.
  • 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.
  • 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:

  • Strong working knowledge of clinical laboratory science
  • Excellent verbal and written communications 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 Trouble shooting 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.

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.

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