Production Group Lead - (Biotech)

Production Team Lead Assists in coordinating production activity in assigned work areas, ensuring that product is continuously processed in accordance with build schedules. Coordinates communication of work instructions to personnel in designated areas in accordance with supervisory objectives. Ensures that quality and production goals are met. Performs regular process and quality performance audits of personnel, tooling and equipment in assigned areas. Advises supervisor or other appropriate contacts in the event of equipment failure. Accumulates information for assigned areas regarding work in process inventory status and daily output quantities. Assists in providing direct training to area operators as required. Provides feedback on defects encountered, and provides re-training support as necessary. Provides assistance in expediting priority product and tasks in assigned areas. Performs inspection and determines disposition of rejected components per required documentation, as directed. May perform direct manufacturing operations in support of build schedules, as directed or as necessary. Remains current on developments in field(s) of expertise, applicable regulatory requirements, and a general knowledge of the companys products, markets, and objectives as well as industry trends. Coordinates purchase requests for equipment and services. Resolves and/or facilitates resolution of problems including identifying causes to prevent re-occurrence. Daily meeting with manufacturing operators for better communication and continuous improvement. Ensures PM (preventive maintenance) and Calibration stickers are up to date. 5S audit and weekly meeting with other area value stream group-leads in an organization. BBSP Observation Help with any employee needs (assist with training and Employee Self Service needs). Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Performs other related duties and responsibilities, on occasion, as assigned.