Supervisor, FIlling

Fresenius Kabi USA•Wilson, NC

About The Position

Responsible for supervising and coordinating production personnel and processes within an assigned area. Provides oversight to ensure safe, effective, and efficient operation of manufacturing equipment, conformance to quality standards and applicable SOPs and cGMPs, and compliance with company requirements. Requires a thorough understanding of equipment operation and batch record requirements, and review of production documentation and batch reconciliation.

Responsibilities

Coordinate production schedules and equipment changeovers based on direction from production managers.
Oversee production processes across multiple manufacturing lines on the assigned shift, coordinating activities on the production floor and supervising hourly production employees.
Interact with supervisors, managers, and support groups to maintain compliance with procedures, standards, policies, and cGMPs.
Coordinate batch documentation, including data entry, verification, review, and approval as required.
Take responsibility for production personnel, production metrics, equipment condition, and facility condition.
Ensure compliant application of departmental and company policies and procedures, safety programs, standards, and cGMPs.
Complete timely deviation investigations, conduct root cause analysis, and implement corrective and preventive actions.
Write investigation reports and mitigation plans as required.
Monitor and control production schedules and activities to meet departmental performance objectives and budgets.
Update and enhance departmental SOPs.
Recommend and implement value and process improvement programs.
Coordinate staffing for the assigned area and ensure personnel training is current.
Develop and execute training and follow-up programs to support staff development.
Regularly evaluate operations personnel performance.
Establish effective communication methods to maintain continuity of information across operations and shifts.
Empower assigned personnel to define and recommend continuous process improvements.
Contribute to development of the annual departmental operating budget and provide daily performance updates.
Perform other duties and responsibilities as assigned.