Aseptic Process Mentor: Elevate GMP Compliance & Training

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

Benefits offered by this job

401(k) plan with company contributions

Paid vacation, holidays and personal/休

Health, dental and vision benefits

Employee assistance program

Job summary

Fresenius Kabi USA in Melrose Park, IL is seeking a professional to monitor aseptic core operations, mentor operators, and ensure GMP compliance. The role emphasizes daily audits, corrective actions, and collaboration with Production, Quality, and Training leadership.

Responsibilities include training in aseptic techniques, documenting results, and supervising in the aseptic core. The position offers health benefits, a 401(k) plan, paid time off, and a strong focus on maintaining sterile

Qualifications

• Bachelor’s Degree in Microbiology or Life Sciences, or an Associate/Certificate with 1–3 years in pharma manufacturing.
• Aseptic Processing experience with gowning qualifications is desirable.
• Ability to gown and work in an aseptic manufacturing environment.
• English language proficiency required for procedures and communications.

Responsibilities

• Monitor Filling Operators by daily visual audits of aseptic behavior inside the core during fills and lyophilizer loading.
• Take immediate action for non‑compliance or undesired behavior by personnel.
• Partner with Production/Quality/Training Leadership to improve aseptic processes.
• Communicate openly to operators and supervisors to provide mentoring on observed performance.
• Provide corrective action training based on audits and feedback.
• Complete daily inspections of the aseptic core conditions.
• Review aseptic technique with media fills and assist with documentation and vial count verification.

Skills

Aseptic technique

Mentoring

Visual audits

Documentation

Education

Bachelor’s Degree in Microbiology or Life Sciences

Associates Degree/Certificate in pharma manufacturing + 1–3 years experience

Job description

Fresenius Kabi USA in Melrose Park, IL is seeking a professional to monitor aseptic core operations, mentor operators, and ensure GMP compliance. The role emphasizes daily audits, corrective actions, and collaboration with Production, Quality, and Training leadership.

Responsibilities include training in aseptic techniques, documenting results, and supervising in the aseptic core. The position offers health benefits, a 401(k) plan, paid time off, and a strong focus on maintaining sterile