Aseptic Process Mentor (Weekend)

Fresenius Kabi USA•Grand Island, NY

9d•Onsite

About The Position

This role monitors the aseptic core to ensure continuous compliance with Good Manufacturing Practices (GMPs) and provides mentoring on aseptic technique to operators. The position also involves reporting key metrics to site management on a regular basis. The role is compensated with an hourly rate of $23.45, plus a $3.00 shift differential and an 11.1% shift premium. The working hours are Friday through Sunday, from 11:15 AM to 12:30 AM. Final pay will be determined by factors such as 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.
Proficiency in Aseptic Gowning.
Experience 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.