Job Title: QC Microbiology Specialist
Job ID: 551
City: Wakefield
State: Massachusetts
Job Type: Full Time On-Site/Part Time On-Site/Full Time Remote/Part Time Remote/Full Time Hybrid
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.
- 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.