Job Title: Aseptic Process Monitor
Pay: $20.00 - $22.00 per hour, plus $1.50 shift differential
Job Overview: Monitors aseptic core to ensure continual compliance with GMP's 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.
- Expected to train personnel in Aseptic Techniques and processes.
- Reports metrics and trends to site management on a regular basis.
- 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.
- Bachelor Degree in Microbiology or Life Sciences or a Certificate with a focus on pharmaceutical manufacturing plus one to three years of related experience.
- Aseptic Processing experience, including proficiency in Aseptic Gowning qualifications is desirable.
- The ability to gown and work in an aseptic manufacturing environment.
- Depth Perception - three-dimensional vision. Ability to judge distance and space relationships. - 90%
- Field of Vision - area that can be seen up and down or left and right. - 90%
- Standing - remaining in an upright position at a workstation without moving about. - 90%
- Walking - moving about on foot. - 70%
- Talking - expressing or exchanging ideas by means of the spoken word. - 50%
- Sitting - remaining in the normal seated position. - 10%