Night-Shift Formulation Supervisor, Parenteral Production

Fresenius Kabi USA; Town of Grand Island (NY); On-site; USD 74,000 - 103,000; Full time

Job summary

Fresenius Kabi USA in Grand Island seeks a Formulation/Production Supervisor to oversee the Grand Island formulation suites and related clean environments, ensuring schedules, quality, and compliance with SOPs, DEA, OSHA and cGMPs.

The role directly supervises 12–15 staff, drives staff development, hiring and disciplinary processes, and collaborates with HR, Maintenance, and Quality to maintain safety, training, and timely batch records.

Qualifications

• High School diploma or GED. BS/BA in Science related discipline or equivalent relevant work experience is preferred.
• 4-5 years of pharmaceutical experience in compounding preferred.
• Working knowledge of SOPs and cGMPs rules and regulations.
• Must be able to work with Antineoplastic products and assist in the Nanotechnology department.
• Heavy lifting is required. (Ability to regularly lift 25 lbs and occasionally lift 50 lbs without strain.)

Responsibilities

• Ensures adequate systems are in place to effectively manufacture Bulk product, and clean/store/prepare equipment.
• 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

Skills

Pharmaceutical compounding

Staff supervision

Quality compliance

Education

Bachelor's degree in science

Tools

Microsoft Office

Job description

Fresenius Kabi USA in Grand Island seeks a Formulation/Production Supervisor to oversee the Grand Island formulation suites and related clean environments, ensuring schedules, quality, and compliance with SOPs, DEA, OSHA and cGMPs.

The role directly supervises 12–15 staff, drives staff development, hiring and disciplinary processes, and collaborates with HR, Maintenance, and Quality to maintain safety, training, and timely batch records.