Aseptic Process Coach & Mentor

301044 Fresenius Kabi USA, LLC; Melrose Park (IL); On-site; USD 28,000 - 40,000; Full time

Job summary

Fresenius Kabi USA, LLC in Illinois seeks a QA/ aseptic specialist to monitor aseptic filling operations, mentor operators, and ensure GMP compliance. The role requires conducting daily audits, providing immediate corrective action training, and supporting documentation and vial counts for aseptic processes.

Ideal candidates hold a Bachelor’s in Microbiology or Life Sciences with 1–3 years of related experience, aseptic processing proficiency, and strong English communication in a regulated

Qualifications

• Bachelor’s Degree in Microbiology or Life Sciences or equivalent.
• Aseptic Processing experience desirable.
• Strong English reading/writing/speaking skills for a regulated environment.

Responsibilities

• Monitor filling operators with daily visual audits of aseptic behavior in 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 recommend aseptic process enhancements.
• Communicate openly to operators and supervisors to provide mentoring on observed performance.
• Provide corrective action training based on visual audits with immediate feedback.
• Complete daily inspections of the aseptic core conditions.
• Review aseptic technique for media fills and assist with documentation and final vial count verification.

Skills

Aseptic technique

Quality awareness

English communication

Education

Bachelor’s Degree in Microbiology or Life Sciences

Associates Degree or Certificate in pharma manufacturing

Job description

Fresenius Kabi USA, LLC in Illinois seeks a QA/ aseptic specialist to monitor aseptic filling operations, mentor operators, and ensure GMP compliance. The role requires conducting daily audits, providing immediate corrective action training, and supporting documentation and vial counts for aseptic processes.

Ideal candidates hold a Bachelor’s in Microbiology or Life Sciences with 1–3 years of related experience, aseptic processing proficiency, and strong English communication in a regulated