Aseptic Support Supervisor (Mon-Thurs 1:30p-11:00p)

About the role

The Aseptic Support Supervisor oversees aseptic support operations within a 503B outsourcing facility, ensuring compliant execution of production activities that meet FDA, cGMP, and internal quality standards.

Responsibilities

• Supervise aseptic support, staging support, and coordinator operations.
• Review operator adherence to HR policies and perform disciplinary action when necessary.
• Approve electronic time keeping for reports.
• Manage personnel to operational standards and complete performance evaluations.
• Partner with the new product development team to ensure components and batch records are ready to maintain adherence to the schedule.
• Review and maintain adherence to the manufacturing schedules.
• Aid in inventory control by ensuring personnel are properly documenting and consuming components and material in an ERP system.
• Track employee training to ensure compliance.
• Aid in bi-annual reviews of procedures.
• Provide on-the-floor leadership to the operational team.
• Ensure safety is followed with equipment, and certifications are up to date.
• Works with FSS2 staff to oversee transfers from FSS2 to FSS1.

Qualifications

• Demonstrated knowledge of cGMP pharmaceutical manufacturing, sterile production environments, and 503B regulatory expectations.
• Previous supervisory or lead experience in cleanroom, aseptic, or pharmaceutical operations preferred.
• Strong understanding of documentation practices, ERP systems, and material flow in regulated manufacturing environments.