- Oversees implementation of skills training and safety programs to ensure employees work in compliance with all company SOPs, policies, cGMPs and applicable safety and regulatory requirements
- The Aseptic Manufacturing Supervisor is responsible for commercial manufacturing operations. The position ensures the effective scheduling and utilization of facilities,
- equipment and personnel in producing quality products meeting customer delivery requests and internal performance targets.
- Provide floor leadership, supervision and hands-on training for all aseptic Manufacturing personnel
- Optimize resources within assigned areas to ensure efficient compliant operations
- Participate in projects and activities which support company goal
- Supervise daily manufacturing activities including dissolution, filtration, formulation, aseptic filling, lyophilization, visual inspection and bulk packing
- Review GMP documents for compliance and accuracy
- Coordinate activities with other operational groups (quality, facilities, materials, packaging) to ensure schedule adherence
- Collaborate with Quality Assurance to address deviations, perform investigations, support change controls, and implement corrective/preventive actions
- Ensure MRP compliance for all manufacturing related activities are completed accurately and within allotted time frames
- Responsible for the development and coaching of employees to ensure the proper level of performance and behavior
- Assist performance appraisals and organizational audits to assess the current and future needs of the organization and implement plans to assure future needs are addressed
- Ability to solve aseptic problems and deal with a variety of situations where critical problem solving is required