Personal Information
Organization / Workplace
Raleigh-Durham, North Carolina Area United States
Occupation
Associate Director, QC
Industry
Medical / Health Care / Pharmaceuticals
About
Over 20 years experience in Quality management and quality systems, proven leader for quality. Over twelve years in leadership roles, progression in responsibility. Extensive experience in Quality Control laboratories and QA functions include Change control/impact assessments, Document sponsor/approver, Quality auditing and inspection readiness. QA management in disposition and release of materials and product impact assessments including formal risk assessments. Review and closure of investigations (Trackwise/SAP systems). Change Control, internal and external auditing. Experience in bulk manufacturing, API, final product and intermediate products. Accountability and Management of Q...
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