Works as a consultant and project lead, assisting a variety of companies from different categories (medical device, pharmaceuticals, etc.) to create procedures, protocols, validations (EO sterilization, Radiation Sterilization, Steam Sterilization, Reusable Devices), and reports as well as performing risk and gap assessments, biocompatibility assessments, etc. Performs other technical writing as required. Creates training material for purchase.

Worked as a sterilization and microbiology SME for a contract manufacturing company. Provided technical expertise on CAPAs, NCMRs, and change assessments. Facilitated sterilization validations and generated reports and protocols. Ensured technical related compliance to standards and regulatory bodies. Provides technical expertise for internal and customer related audits. Lead auditor for supplier audits. Member of AAMI working groups.

Worked on routine EO sterilization cycle review and investigations. Provided SME expertise on CAPAs and change orders. Facilitated sterilization validations and generated reports and protocols. Worked on Cleaning Validation studies. Ensured compliance to standards and regulatory bodies. Provided SME expertise for EU MDR submission. Created training seminars.

Analyst who performed and trained others to quality control tests and microbiology techniques. Worked to provide technical expertise to CAPAs, NCMRs, as well as equipment validations. Functional understanding of compliance and regulatory bodies related to pharmaceuticals.

Laboratory technician who performed and trained others to a variety of quality control tests and microbiology techniques on medical devices, pharmaceuticals, cosmetics, and miscellaneous samples. A Lean facilitator and champion who lead process improvement teams. Performed steam sterilization validations.