Incumbent performs routine laboratory procedures in accordance with established Covance CLS quality principles, as well as trains new employees on the same. Incumbent is responsible for validating and maintaining new assays. Incumbent offers strong analytical knowledge in use and maintenance of sophisticated high technology instrumentation in the area of responsibility and expertise. Incumbent has high initiative with proven troubleshooting skills in major areas of departmental responsibility. Incumbent maintains high standards in all aspects of departmental and laboratory functions. Additionally incumbent is responsible for performing functions in 2 of 3 functional capacities: Training (required), Technical/Scientific and/or Operations/Processes.
May perform duties of Technologist I, II or III in addition to the following additional duties:
Essential Functions – Training (Required)
♦ Provides informal leadership to department staff through mentoring and coaching.
♦ Oversee training activities within the department to ensure accuracy, quality, and consistency. Ensure area personnel are appropriately trained to support on-going routine production. Ensure training is completed as scheduled, and is properly documented prior to the individual testing and reporting patient results.
♦ Ensure competency is completed, as scheduled, by periodic review of competency documentation.
♦ Oversee the timely and accurate development of training materials and checklists for the department/sites.
♦ Provide on-going guidance, and support to department staff for training needs.
♦ May provide feedback to management on staff performance evaluations.
Essential Functions – Technical/Scientific
♦ Act as a consultant to the lab management, internal customers, and clients in all technical/scientific facets relating to departmental activity. o Manage inquiries/requests for supporting documentation regarding data, test methodologies, new test codes, worksheets, and other internal customer/client needs.
o Attend customer team meetings, and participate in client conference calls where needed.
o Serve as site resource to provide guidance/direction to global sites for implementation of new processes/changes, and facilitate resolution of global issues.
o Drive timely implementation of new assay validations, instruments, and equipment according to SOPs.
Essential Functions – Operations/Processes
♦ Serves as a subject matter expert (SME) for new initiatives, Six Sigma projects, and other process improvement projects.
♦ Effectively utilizes performance measures/metrics to identify potential opportunities to drive improvements in quality, cost, cycle time, and service.
♦ Performs research to support requests for new instruments/equipment needed to implement new assays, improve productivity, and reduce costs. Works with potential vendors, and provides necessary information to internal customers for implementation.
♦ Oversee delegation of workflow. Ensures the efficient operation of workstations and areas of responsibility to ensure timely resulting of quality data.
♦ With management, may lead cross-site harmonization efforts.
♦ Provide support to management for relationships with vendors to ensure company resource needs are met and issues are addressed.
♦ 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.