QC Microbiology Specialist

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.

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.