Clinical Lab Specialist (Must Have Clinical Exp) - No Microbiology, Covid testers, Chemical lab

About the role

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.

Responsibilities

• 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
• 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.

Requirements

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.