QC Microbiology Specialist
Carlton National Resources
QC Microbiology Specialist
Position Overview: The QC Microbiology Specialist plays a crucial role in quality control, focusing on microbiological testing, aseptic processing, and environmental monitoring. This position supports quality improvement and compliance within a sterile manufacturing environment.
Key Responsibilities:
- Oversee the management of MODA-EM and LIMS systems, ensuring accurate test configurations and user requirements.
- Develop and implement trending programs, environmental monitoring protocols, and aseptic process simulations.
- Conduct microbial testing, deviation investigations, and CAPA processes to resolve quality issues.
- Monitor and analyze environmental and utility monitoring data, setting alert and action limits for compliance.
Required Qualifications:
- Bachelor's degree in Microbiology, Life Sciences, or a related field.
- 5+ years of experience in QC microbiology within sterile manufacturing.
- Knowledge of regulatory guidance (FDA, EU, JP) and experience with aseptic processing, bioburden testing, and environmental monitoring.
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