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location: Melrose Park, Illinois
job type: Contract
salary: $20.00 - 25.42 per hour
work hours: 9 to 5
- Monitors aseptic core to ensure continual compliance with GMP's and provides mentoring on aseptic technique with operators. Reports metrics to site management on a regular basis.
- 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.
- Expected to train personnel in Aseptic Techniques and processes.
- Reports metrics and trends to site management on a regular basis.
- Assumes additional duties and responsibilities as assigned.
- Bachelor Degree required in Microbiology or Life Sciences or a Certificate with a focus on pharmaceutical manufacturing plus one to three years of related experience.
- Aseptic Processing experience, including proficiency in Aseptic Gowning qualifications is desirable.
- The ability to gown and work in an aseptic manufacturing environment.
- 1-3 Years of experience
skills: GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.