Aseptic Process Mentor (Weekend)

Fresenius Kabi•Grand Island, NY

7d•$23•Onsite

About The Position

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. This is a weekend position with specific shift hours and a competitive hourly rate including shift differential and premium. Final pay is determined by experience, education, knowledge, skills, and abilities.

Requirements

Bachelor’s Degree in Microbiology or Life Sciences, or a Certificate with a focus on pharmaceutical manufacturing, or converted years of experience as an Aseptic Control Operator and qualified trainer.
2 years of Aseptic Processing experience, including proficiency in Aseptic Gowning, and working in an aseptic manufacturing environment.

Responsibilities

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.
Train personnel in Aseptic Techniques and processes.
Report metrics and trends to site management on a regular basis.
Assume additional duties and responsibilities as assigned.