Quality Compliance professional with experience in Quality Audits, Product Project Management, CMC document review, and Quality Risk Management. Also, experienced in management of non-conformance compliance, audit procedures, instituting permanent inspection readiness, and project management. Consultant for aseptic processing, engineering process improvements, and quality planning. Risk-based quality practices that are aligned with regulatory requirements and internal quality standards. Focused on meeting compliance objectives and client needs.
Biotechnology: Drug Development and Product Management
Associates in Biology
Consultant to CDMOs on Compliance, QA and RA needs. Lead projects based on company needs. Biotech manufacturing, vaccine manufacturing, and medical device companies.
Lead of compliance department. Reduced turn around times for product disposition and client complaint compliance.
Tech Ops compliance specialist. Deviation investigations technical writer and CAPA management, process improvement lead, and change control management.
CAPA and change control specialist. Technical writer for procedure improvements for Quality Control, Product Development and Manufacturing.
Lab technician, procurement management, maintenance of automated equipment, maintenance of bio-library.