Aseptic Production Supervisor; Day Shift

Aseptic Production Supervisor (Day Shift)

The Aseptic Operations Supervisor is responsible for supporting, coordinating, scheduling, and maintaining all manufacturing activities. The Supervisor also oversees component preparations, filling, capping, autoclaving, depy glass, compounding, filtration, filling, lyophilization, and terminal sterilization of finished product production.

• Ensure systems and resources meet production schedules and that products are manufactured to specification and in accordance with SOPs, cGMPs, and safety procedures.
• Provide and supervise instructions to the manufacturing department to ensure all activities follow GMP, safety, SOPs and Niagara policies.
• Review and update SOPs, deviations, and CAPAs and perform roles directed by upper manufacturing management.
• Supervise manufacturing group leaders and hourly staff in proper operating aseptic techniques.
• Oversee all hourly employees in the performance of their duties.
• Develop and compile reports concerning scheduling, production goals, equipment and maintenance problems.
• Coordinate manpower needs with the training department to achieve personnel training.
• Monitor production schedules and data during manufacturing activities.
• Drive employee and equipment productivity to achieve optimum results.
• Implement strategy from upper manufacturing management.
• Provide clear updates, goals, and direction to the team in support of the daily production plan.
• Coordinate scheduling of operations with other department management to achieve required deadlines.
• Develop department employees through orientation, training, objectives, and communication of rules and policies while building morale and motivation.
• Maintain compliance with company policies, cGMPs, safety standards, and good housekeeping practices.
• Control production schedules and activities to meet departmental performance objectives and budgets.
• Supervise, coordinate, and control production and operating activities to optimize personnel, materials, and equipment utilization.
• Conduct continuous review and follow‑up on projects to ensure completion of assigned work.
• Review documents such as protocols, batch records, change controls, deviations, CAPAs, risk assessments, etc.
• Evaluate staff performance and maintain performance records.
• Advise department management on daily operations and recommend improvements.
• Recommend and implement value and process improvement programs.
• Ensure adequate resources (equipment, supplies, labor) are available to manufacture product.
• Support investigations and ensure prompt document corrections or modifications.
• Ensure direct reports are trained and work in compliance with applicable SOPs, GMPs, regulatory requirements, safety, environmental and company policies.
• Listen to Group Lead feedback and address team members’ feedback.
• Monitor team members’ performance to ensure all training is current and determine if additional training is needed.
• Provide daily leadership and direction to Group Leads and employees.
• Ensure batch production records are correctly filled out and completed in a timely fashion before QA review.
• Demonstrate the ability to set up and operate any equipment used in the immediate work area.
• Troubleshoot equipment and problem‑solve issues that arise.
• Perform all other duties as assigned.

Minimum Qualifications

• 4 years’ experience in field or similar manufacturing environment.
• 4 years’ experience in this position.
• 4 years’ experience managing people or projects.
• Experience may include a combination of work experience and education.

Preferred Qualifications

• 6 years’ experience in field or similar manufacturing environment.
• 6 years’ experience working in this position.
• 6 years’ experience managing people or projects.
• Experience may include a combination of work experience and education.

• Proficiency with tools, equipment, or work aids (beginner, intermediate, advanced).
• Performs work under direct supervision.
• Handles basic issues and refers more complex issues to higher-level staff.
• Possesses beginning to working knowledge of subject matter.
• Strong verbal, writing, and presentation skills.
• Analytical and problem‑solving skills.
• Ability to…