Grand Island, New York
Fresenius Kabi
Job Summary
Responsible for the day-to-day supervision of 30 – 50 employees on the Inspection and Packaging lines. Provides oversight to ensure a safe, effective and efficient process for inspection and packaging a quality product. Ensures department meets all quality standards by following all applicable SOP’s and cGMP’s. Has a thorough understanding of all batch record pages and reviews all documentation during production and reconciliation to prevent errors. Accuracy and attention to detail is a critical aspect of this position. Must relate professionally with support groups and all levels within the organization.
Responsibilities
1. Day to day supervision of 30 – 50 employees across multiple Inspection / Packaging lines.
2. Coordinates the execution of production schedules based upon customer demand.
3. Interacts with departmental supervisors and support groups on maintaining compliance with methods, standards, policies and cGMP’s.
4. Completes all batch related documentation according to site release standards.
5. Assumes responsibility of their assigned department during course of shift.
6. Write Investigation reports as they pertain to Inspection / Packaging errors. 7. Defines, recommends and performs corrective and preventative actions.
8. Writes Mitigation plans as needed.
9. Update and enhance departmental SOP’s.
10. Contributes to development of annual departmental operating budget.
11. Regularly evaluates performance of Inspection / Packaging personnel.
12. Coordinates application of operators in assigned areas of responsibility.
13. Develop, execute and track training and follow-up programs to ensure adequate staff development.
14. Establishes effective communication methods to provide continuity of information across all shifts.
15. Provides a daily update on performance.
16. Assume other duties and responsibilities as assigned.
17. Promotes continual improvement taking accountability for the effectiveness of the Environmental/Energy Management System.
18. Responsible for ensuring Health, Safety and Environmental requirements are adhered to
REQUIREMENTS
Bachelor’s degree and/or related equivalent experience.
3 – 5 years in an FDA regulated industry.
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, disabilities, or protected veteran status.