I am an experienced Quality Assurance/Quality Control professional with experience in the Medical Device, Biotechnology and Pharmaceutical Industries. Managed QA/QC operations of pharmaceutical and medical diagnostics manufacturing facilities.
Managed the Internal Audit program at Biomet 3i. Exercised Quality Assurance oversight of the Cangene contract manufacturing facility in Winnipeg, Canada.
Experienced in Cleaning, Process and Methods validation.
Served as CAPA engineer assisting CAPA owner with problem statements, root cause analysis, corrective action and preventive actions.
Served as escort during FDA regulatory inspections.
Knowledgeable 21 CFR 820 Quality Systems Regulations, ISO 138485 Quality Management Systems- Requirements for regulatory requirements and ISO 14971 Medical Device Risk Management.