You will be responsible for implementing and supervising daily activities in a specific production area to ensure manufacturing goals and project deadlines are met while maintaining compliance with current good manufacturing practices (GMPs), environmental health and safety (EHS) guidelines and any other regulations that could apply. May monitor and control labor. Responsible for supervising the day-to-day production, scheduling, staffing, material management, compliance, training and auditing activities –to meet customer requirements including deadlines and quality standards. Audit, refine, and improve processes and equipment operation within the manufacturing areas. Drive to utilize resources and raw materials in the most efficient and productive manner possible. Support and Emphasize the Safety and Quality commitments of the department. Interview, hire, coach, motivate, develop and discipline staff. Conduct annual performance reviews for all direct reports. Assist in setting performance objectives and development plans. Monitor progress. Facilitate and verify appropriate training for employees in the area. Review, approve, and manage documentation for batch and system records. Assist in release of product for distribution. Assist in meeting product release time goals. Develop and implement performance measurement and internal auditing programs in order to routinely evaluate operation efficiency and quality. Implement changes as needed based on assessments. Represent the Company during FDA inspections. Provide information as necessary to FDA that establishes credibility and demonstrates compliance with cGMPs. Provide a positive and equitable working environment emphasizing the Baxter. Submit and/or maintain and distribute reports related to attendance, labor, efficiency, safety, scrap and others as needed.
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