Aseptic Process Mentor – GMP Training & Compliance

301044 Fresenius Kabi USA, LLC; Melrose Park (IL); On-site; USD 29,000 - 40,000; Full time

Benefits offered by this job

401(k) plan with company contributions

Paid vacation, holidays and personal

Job summary

Fresenius Kabi USA, LLC is seeking a microbiology/life sciences professional for the aseptic core monitoring role at our Melrose Park, IL site. The position involves monitoring aseptic behavior during fills and lyophilizer loading, training personnel, and ensuring compliance with GMP and aseptic techniques.

Requirements include a Bachelor’s degree in Microbiology or Life Sciences (or related cert) and 1–3 years of related experience.

Qualifications

• Aseptic processing experience desirable.
• Proficiency in aseptic gowning qualifications.
• Able to read, write and understand English in a regulated 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 or undesired behavior is observed.
• Partner with Production/Quality/Training Leadership to propose enhancements to aseptic process.
• Provide mentoring regarding observed performance to operators and supervisors in the aseptic core.
• Complete daily inspections of the physical conditions of the aseptic core and verify documentation and vial counts.

Skills

Aseptic technique

English communication

Education

Bachelor's Degree in Microbiology or Life Sciences

Job description

Fresenius Kabi USA, LLC is seeking a microbiology/life sciences professional for the aseptic core monitoring role at our Melrose Park, IL site. The position involves monitoring aseptic behavior during fills and lyophilizer loading, training personnel, and ensuring compliance with GMP and aseptic techniques.

Requirements include a Bachelor’s degree in Microbiology or Life Sciences (or related cert) and 1–3 years of related experience.