Clinical Laboratory Specialist

13 hours ago


Columbus, Ohio, United States MILLENNIUMSOFT Full time
Clinical Laboratory Specialist Job Description

We are seeking a highly skilled Clinical Laboratory Specialist to join our team at Millenniumsoft. As a key member of our laboratory team, you will be responsible for managing clinical laboratory studies and complaint testing through various clinical testing methods.

Key Responsibilities:
  • Apply laboratory knowledge to manage complaint testing through design of testing methods to verify customer complaints.
  • Execution of the testing with human blood using the appropriate laboratory equipment and drafting the testing summary based on the data and findings of the investigation.
  • Provides input to and conducts scientific investigations in areas of considerable scope and complexity.
  • Explores, identifies, and recommends solutions, 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.
Requirements:
  • BS/BA/MA in Clinical Laboratory Science or Medical Technology, Biology Life Sciences, or a health-related field required.
  • MT/CLS (ASCP) or equivalent experience in a Research environment.
  • 5+ years' experience in clinical laboratory science or in clinical research, product investigations, troubleshooting abnormal laboratory results, and product development with clinical trials' experience desired.
  • Phlebotomy is a plus.
About Millenniumsoft:

Millenniumsoft is an American multinational medical technology company that manufactures and sells medical devices and also provides consulting and analytics services in certain geographies.

It was one of the first companies to sell U.S.-made glass syringes. It was also a pioneer in the production of hypodermic needles and ranked #195 in the 2019 Fortune 500 list.

It was also listed among the top 100 companies in Newsweek's 2009 Green Rankings. Ranking of the 500 largest American corporations based on environmental performance, policies, and reputation. Placed third in the health care sector and 83rd overall



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