Job Summary

Responsibilities

Responsible for the overall supervision, direction, and coordination of the Grand Island formulation suites and the surrounding controlled environmental area associated with the formulation of liquid parenterals. Ensures adequate systems, equipment and resources are in place to meet production schedules, and that products are manufactured to specification and in complete accordance with applicable SOP's, DEA, OSHA and cGMP's regulations.

Salary Range: $73,614 - $103,000 Annually + 6% Bonus
Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.

Ensures adequate systems are in place to effectively manufacture Bulk product, and clean/store/prepare equipment and compounds.
Ensures all area SOPs are reviewed/revised to encompass any changes in procedure and/or two-year review.
Ensures adequate resources are available to clean and prepare equipment.
Ensures all area personnel are current in their training requirements; Trains employees to area-specific Curricula and company policies and procedures.
Ensures a safe work environment and that all personnel work in a safe manner.
Ensures corrective actions for investigations and audit observations are completed in a timely manner. Ensures all documentation is correct and addresses errors effectively and expeditiously. Completes Batch Record review for area in the designated time expectations.
Works closely with HR on policy changes, interpretation and execution, hiring of new employees, employee disciplinary action, performance appraisals and performance management.
Works with Technical Services/Maintenance to reduce downtime and improve equipment reliability; Assists with design of new systems/facilities related to the department.
Works closely with Material Management and Quality regarding component problems and inventory maintenance. In addition to each complexes inventory management and movement via SAP modules.
Works closely with Environmental, Maintenance, Metrology, and Validation to ensure area environmental monitoring, PM, calibration, and re-qualification schedules are met

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 contribution, 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.

Fresenius Kabi

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