at Fagron Sterile Services in Wichita, Kansas, United States
Job Description
The Aseptic Support Supervisor is responsible for overseeing aseptic support operations within a 503B outsourcing facility, ensuring compliant execution of production activities that meet FDA, cGMP, and internal quality standards. This role provides daily leadership to aseptic support, staging, and coordination teams to ensure safe, accurate, and timely preparation of materials used in sterile manufacturing.
Key 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
