Job Summary
Responsibilities
- Coordinates the execution of the production schedule and equipment changeovers based upon direction from the production managers.
- Oversees the production processes on their assigned shift, across multiple manufacturing lines, working on the production floor to coordinate all relevant production activities and supervise hourly production employees.
- Interacts with supervisors, managers and support groups to maintain compliance with procedures, standards, policies and cGMP’s.
- Coordinates batch related documentation including, data entry, verification, review and approval as required.
- Assumes responsibility for production personnel, production metrics, equipment condition and facility condition.
- Assures the compliant application of departmental and company policies and procedures, safety programs, standards and cGMP’s.
- Completes thorough deviation investigations timely, performing detailed root cause analysis and implementing corrective and preventative actions.
- Writes Investigation reports and mitigation plans as required.
- Monitors and controls production schedules and activities to ensure departmental performance objectives and budgets are met.
- Update and enhance departmental SOP’s.
- Recommends and implements value and process improvement programs. Coordinates staffing for their assigned area of responsibility and assures personnel training is up to date.
- Develops and executes training and follow-up programs to enhance staff development. Regularly evaluates performance of operations personnel. Establishes effective communication methods to provide continuity of information across all operations and shifts.
- Empowers assigned personnel to engage in defining and recommending continuous process improvements.
- Contributes to development of annual departmental operating budget. Provides a daily update on performance.
- Assume other duties and responsibilities as assigned.
- All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities
Requirements:
- Bachelor’s degree and/or related equivalent experience
- Minimum of 5+ years related experience. Previous experience in a FDA regulated industry preferred.
- Good oral and written communication skills
- Working knowledge of SOP’s and cGMP’s
- Accuracy and attention to detail
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
