Personal Information
Organization / Workplace
San Francisco Bay Area United States
Occupation
Quality Assurance & Quality Control
Industry
Medical / Health Care / Pharmaceuticals
About
QA/QC Generalist with 20+ years of experience in the pharmaceutical industry (15 years cGMP experience) including QA/QC managerial positions as well as establishing and implementing quality systems for small molecules and biologics from early phase development through commercialization.
Experienced in DHHS, NIAID, FDA, State of California, and client/partner due diligence inspections and audits.
Vast cross-cultural experience working with partners, clients, vendors, CMO's, CRO's, and clinical sites in Japan, Korea, Spain, United Kingdom, Europe, Australia, Russia, Ukraine, and India.
Specialties:
GxP Training (Instructional Design & Delivery)
Document Control Management
Validation (...
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