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.
- 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.