Clinical Lab Specialist

MUST HAVE A VALID LICENSE THAT DATES THE LENGTH OF THE ASSIGNMENT. A COPY OF THE LICENSE WILL BE NEEDED TO BE PRESENTED BEFORE THE INTERVIEW.

Description :

• Provides input to and conducts scientific investigations in areas of considerable scope and complexity. Explores, identifies and recommends solution, concepts and principles.
• 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.
• 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.

Qualification :