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.