♦ Instrument/Equipment/Assay Validation
o Responsible for coordinating with other resources to ensure timely completion and implementation of new assay validations.
o May be asked to research, develop, validate and maintain procedures in area of responsibility and make recommendations on modification/improvement of procedures to management.
In addtion to validations, the following is required:
o Demonstrates thorough working knowledge of instruments/equipment in the department. Able to provide troubleshooting guidance to staff to resolve complex instrument and equipment problems. Works with the vendor where needed to resolve instrument/ equipment related problems and summarize results of investigations.
o Coordinates the timely development and completion of training materials and checklists. o Seeks and promotes expertise in department and across sites to ensure consistent approach to training.
o Initiates revisions to SOPs or writes new SOPs to reflect current processes that ensure compliance. Coordinates with other departments and other sites to ensure timely completion of SOP. Resolves obstacles, where needed.
♦ Process Improvement:
o Able to analyze existing processes and create new approaches or ideas to improve. Works with internal/external department to ensure successful implementation of changes /improvements. o Demonstrates extensive knowledge of all department functions, and may serve as subject matter expert for department on company wide initiatives (i.e., Six Sigma).
♦ Supports client audit process and responding to inquiries.
♦ Serves as an expert in all facets of trained workstations in area of responsibility. Responds to problems or questions of department staff.
Bachelor’s degree in a bio-medical, physical or biological science from an accredited college or university and one year training and/or experience in the specialty in which testing is to be performed.
Individual must have 3 or more years of Covance Laboratory experience performing clinical laboratory testing or experience in performing clinical laboratory testing judged as equivalent
Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed