Microbiologist
- Conducted environmental monitoring in controlled rooms (ISO classified), analyzing airborne particles, surface contact, and water (chemical and microbiological).- Evaluated cleanroom performance through statistical analysis, recommending corrective actions.- Hosted internal/external audits, managed backroom activities, and organized documentation for auditors.- Led quality improvements in laboratory procedures and documentation.- Validated and operated bioburden testing on medical devices as well as the historical trends. - Coordinated ethylene oxide and radiation sterilization projects, reviewed, and approved sterilization certificates. In addition, evaluating the changes of the devices for an annual sterilization or product family assessment according to the ISO Standards.