Responsibilities / Duties:

? Instruments/Equipment:

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.

? Training:

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.

? SOP:

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.

? 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.

? 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.

Non-Essential Functions

? Only individuals that are verified to qualify as supervisory personnel under regulations/standards applicable to the facility (e.g., New York State, CLIA, CAP) may perform periodic review and approval of quality control program records (e.g. quality control data, instrument logs, reagent logs). The SOPs applicable to the department should be consulted to determine records that can be reviewed and approved.

Education / Qualifications

Preferred:

? Bachelor's degree in Medical Technology or completion of at least a 12-month training program in Medical Technology.

OR

? Bachelor's degree in a chemical, 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. Such training must be equivalent to that received in a school of Medical Technology.

Experience

Individual should have >5 years’ external clinical laboratory testing experience or 1 year of Covance Laboratory experience performing clinical laboratory testing.

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