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Job SummaryResponsible 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. This position directly supervises 12 to 15 direct reports accountable for formulating liquid products against delivered production schedules and compliance regulations. Staff development, hiring, disciplinary processes, and direction to complete assigned activities are required. The formulation supervisor ensures the safe and quality focused work environment while accepting accountability for all activities within this position's control. Investigation work, corrective, and preventative Compensation Range - $71,470 -$80,000 Plus 6% Annual BonusResponsibilities- 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.- 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.- Works closely with Environmental, Maintenance, Metrology, and Validation to ensure area environmental monitoring, PM, calibration, and re-qualification schedules are metREQUIREMENTS BS/BA in Science related discipline or equivalent. 2-3 years of pharmaceutical experience. Working knowledge of SOP's and cGMP's rules and regulations. Proficiency in Microsoft Office requiredAdditional InformationWe offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company match, andwellness 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 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.Minimum Salary: 31200.00
Maximum Salary: 31200.00
Salary Unit: Yearly
