Under minimal direction, this position is responsible for the technical oversight of the manufacturing and laboratory services. This position ensures execution of component manufacturing to achieve system production goals and laboratory services which meet customer needs while implementing new operational processes, culture modifications, and integration of systems.
DUTIES AND RESPONSIBILITIES
Provides effective leadership to achieve high levels of service and product quality, financial results, and other criteria in accordance with policies, goals, and objectives.
Hires, supervises, trains, develops, and evaluates performance of assigned personnel. Identifies and effectively resolves personnel issues
Ensures the accuracy, completeness, timeliness, and document control of manufacturing records. May prepare and/or review laboratory reports and records in accordance with SOPs. Takes corrective action and documents incidents. May perform final review of high-complexity testing records per CLIA requirements.
Ensures the department functions in compliance with all regulatory standards and according to defined organizational policies and procedures, including deviation management and effective, timely corrective action at all times.
Ensures the quality of materials and equipment used to meet quality assurance standards. Ensures staff compliance with maintenance, care, and handling of equipment and facilities.
Manages the reporting and resolution of deviations (e.g., errors, quarantine, recall, market withdrawals, equipment/reagent failures, and accidents).
Oversees technical support services and serves are liaison with Medical Affair
Defines and exemplifies department expectations for effective communications within the department and with other departments and operations
Represents the business unit in enterprise functional council meetings, projects and initiatives.
Participates in the annual budget preparation and ensures adherence to approved department budget
Remains abreast of changes and developments in the blood banking industry related to regulations and standards and provides direction to implement required changes. Establishes and maintains a network of professional relationships.