Aseptic Process Mentor — GMP Coach & Trainer

RXinsider LTD.; Melrose Park (IL); On-site; USD 34,000 - 44,000; Full time

Benefits offered by this job

Medical insurance

Dental coverage

Vision coverage

401(k) with company contributions

Wellness program

Life insurance

Disability insurance

Job summary

Fresenius Kabi in Melrose Park, IL seeks an Aseptic Technician to ensure GMP compliance in the aseptic core, mentor operators, and support process improvements. You will monitor fills, perform audits, and help with documentation and training to maintain high standards.

English proficiency is essential in this regulated environment. Qualifications include a Bachelor’s in Microbiology or Life Sciences (or related combo with pharma manufacturing experience) and aseptic processing knowledge.

Qualifications

• Bachelor’s degree or equivalent with related experience in pharmaceutical manufacturing.
• Aseptic processing experience and gowning qualifications are desirable.
• Proficiency in speaking/reading English due to regulatory environment.

Responsibilities

• Monitor aseptic core to ensure GMP compliance and mentor operators.
• Complete daily visual audits of aseptic behavior during fills.
• Provide corrective action training based on audits and feedback.
• Review aseptic technique and assist with documentation and final vial count verification.
• Escort non-gown qualified personnel as needed.
• Train personnel in aseptic techniques and processes.
• Perform daily inspections of the aseptic core facilities.

Skills

GMP compliance

Aseptic techniques

Mentoring operators

Documentation

Education

Bachelor's Degree in Microbiology or Life Sciences

Associate Degree + certificate in pharma manufacturing

Job description

Fresenius Kabi in Melrose Park, IL seeks an Aseptic Technician to ensure GMP compliance in the aseptic core, mentor operators, and support process improvements. You will monitor fills, perform audits, and help with documentation and training to maintain high standards.

English proficiency is essential in this regulated environment. Qualifications include a Bachelor’s in Microbiology or Life Sciences (or related combo with pharma manufacturing experience) and aseptic processing knowledge.