Messina seeks several Aseptic Process Mentors to monitor aseptic cores and ensure continual compliance with GMPs and provides mentoring on aseptic technique with operators. Reports metrics to site management on a regular basis.
- Monitor Filling Operators by completing daily visual audits of Aseptic Behavior inside the core during fills and lyophilizer loading.
- Take immediate action when non- compliance and/or undesired behavior by personnel in the complex is observed.
- Partner with Production/Quality/Training Leadership to make recommendations for enhancements to aseptic process.
- Communicate openly to operators and supervisors in aseptic core to provide mentoring regarding observed performance.
- Provide corrective action training based on visual audit by immediate feedback.
- Complete daily inspections of the physical conditions of the aseptic core.
- Review aseptic technique associated with media fills and help complete documentation and final vial count verification.
- Presence in the Aseptic complex on a regular basis is essential.
- Provide escort of non-gown qualified individuals on an as needed basis.
- Expected to train personnel in Aseptic Techniques and processes.Reports metrics and trends to site management on a regular basis.
- Assumes additional duties and responsibilities as assigned.