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.