Consultant to major pharmaceutical and biomedical companies to support Quality Assurance and Quality Compliance activities in a cGMP environment including: Data Integrity/Data Governance, Computer System/Data Life Cycle Management, Material Control, Product Quality Assessment and Warning Letter Remediation. Recent projects include: B. Braun Medical Inc., Aseptic Fill and Medical Device Facility, Fresenius Kabi, Aseptic Facility, etc.

Product Quality Assessment (Performed retrospective review and assessment of Laboratory and Manufacturing Investigations, CAPAs, Change Controls, Cleaning Validation methods, and critical equipment qualification to assure quality and safety of the product in the market.

QC Chemistry Document Control (Evaluated over 80 methods for compliance with current standards, validation studies or compendia. Developed over 80 worksheets for testing in- process and finished products to replace laboratory notebooks)
Project Management (Managed resources, workflow, project scope and timelines to meet CAPA requirements)