Clinical Lab Specialist
2 weeks ago
MILLENNIUMSOFT is seeking a highly skilled Clinical Lab Specialist to join our team. As a Clinical Lab Specialist, you will be responsible for managing clinical laboratory studies and complaint testing through a variety of 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 finding of the investigation.
- Provides input to and conducts scientific investigations in areas of considerable scope and complexity.
- 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.
- BS/BA/MA in Clinical Laboratory Science or Medical Technology, Biology Life Sciences or 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.
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