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Clinical Laboratory Specialist

Apply Now Job ID R-335571 Date posted 04/19/2019

Job Description Summary

Job Description

Reporting to the Sr. Clinical Laboratory Manager, Medical Affairs, BD Diagnostics - Preanalytical Systems, this laboratory based position will be responsible for managing complaint testing through design of testing methods to verify customer complaints. Knowledge and expertise demonstrating safety and efficacy of new or modified in-vitro diagnostic devices, as well as, to innovation outside of the core business. Possesses technical competence in clinical laboratory disciplines such as chemistry, hematology, coagulation and operation of multiple instrument platforms.  Develop/implement new testing methodologies in collaboration with R&D.  

**This position does not provide relocation assistance**

Responsible for understanding product design and function and applying quality and regulatory standards.  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.

  • 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 and Point of Care testing.
  • Applies laboratory and instrumentation knowledge to manage complaint testing through design of testing methods to verify customer complaints. This includes interpreting complaints appropriately, designing relevant clinical testing to support the complaint.
  • Execution of the testing using the appropriate laboratory equipment and drafting the testing summary based on the data and finding of the investigation. 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, methodology and Computer System Validations.
  • Conducts instrument validation and verification per CLSI guidelines, assists with updates and preparation of procedures and instrument performance documentation in compliance with GLP and GCP.  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 practices and utilizes this information to recommend new projects and influence ongoing projects.
  • Participates in development of the clinical strategy for all BD PAS 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.
  • Accountable for scientific excellence in design, implementation and execution of any studies to support complaint testing, innovation or product development including design verification and validation studies.
  • Involves assessment/development of new technologies through all development phases and post launch phase to determine feasibility for the market as well as ability to meet current customer needs.
  • The key financial impact of this position is the contribution of high-quality, scientific and clinical input to study design and implementation, which are required for successful studies, support the development and launch of new products, as well as resolution of customer complaints through laboratory testing.

Requirements:

  • BS/BA/MS in Clinical Laboratory Science or Medical Technology, life sciences or health related field required.
  • MT/CLS (ASCP) strongly preferred
  • 3-5 years’ experience in clinical laboratory science or in clinical research, product investigations required
  • Phlebotomy knowledge and experience is required
  • Troubleshooting abnormal laboratory results and product development with clinical trials’ experience desired.Strong working knowledge of clinical laboratory science Demonstrated experience working in global cross functional teams, Excellent verbal and written communications skills,
  • Awareness/basic knowledge of GCP/GLP and ISO regulations
  • Experience with 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

Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

Work Shift

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All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com