Clinical Lab Specialist

• 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 practices and utilizes this information to recommend new projects and influence ongoing projects
• Participates in development of the clinical strategy for all BD 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

• 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
• 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
• 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

Phlebotomy is a plus