Sterility Assurance Associate I
Current• Lead the implementation of remote particle counter continuous non-viable monitoring in Grade A classified area. This includes collaboration with third party vendors for the qualification of the units, review of the qualification documentation, completion of a risk assessment for the units, and extensive troubleshooting for equipment malfunction.• Participated in and composed a summary report for Aseptic Processing Simulations. • Maintains a level of expertise regarding equipment and operations to support manufacturing for CCRM and its clients.• Designs, organizes, and maintains Standard Operating Procedures (SOPs) while ensuring compliance with applicable regulations.• Provides guidance in the areas of microbiology, aseptic processing, and Contamination Control program and mitigation planning.• Maintains GDP records for the Environmental Monitoring program, and trend data for the facility at regular intervals. Performed thorough data analysis to develop corrective actions if deviations/adverse trends are observed.• Creates equipment logbooks/records and a Preventative Maintenance (PM) schedule for applicable equipment.• In the event of an “above alert/action limit” deviation, maintain contact with appropriate departments and lead monitoring of such deviations.• Analyses microbiological testing results and manages the third-party testing by our approved partners. Takes part in the qualification processes (as needed) of third-party laboratories.• Performs aseptic gowning qualification and maintaining personnel qualifications.
