QC Microbiologist - Environmental Monitoring

General Responsibilities:
Performs environmental monitoring in support of aseptic product manufacturing, media fill batches, and personnel monitoring. Performs raw material release testing in support of aseptic product manufacturing.
 

Responsibilities:

• Perform viable and non-viable environmental monitoring in support of Manufacturing and Quality Control in the form of air testing, surface testing, personnel testing, and particulate monitoring inside the clean rooms.
• Perform batch record verification of critical processing steps performed by Manufacturing during aseptic product manufacture, ensuring accuracy of steps performed.
• Perform Growth Promotion testing on prepared media.
• Perform environmental monitoring during aseptic process media fills batches.
• Maintain housekeeping in the Quality Control laboratories.
• Assist the Quality Control department in daily operations, as needed.
• Revise QC SOPs as necessary to maintain compliance.
• Respond timely to Out of Specification (OOS) results, including notification to area management.
• Communicate with the individual Operations Departments (Manufacturing, Quality Assurance, Facilities) to ensure that Company objectives are met on schedule.
• Training of other employees as necessary.
• Participation in investigations to ensure that potential problems and root causes are identified, impact assessed, and actions to prevent recurrence are considered and implemented.