Licensed Pharmacist with strong background in quality assurance and regulatory compliance with diverse experience in pharmaceutical industry, retail, hospital, and long-term care settings. Adept at pharmaceutical research, clinical manufacturing, packaging, validation and quality assurance. Broad knowledge of numerous computer programs including Microsoft Office packages, Visual Basic, SAP, LIMS, Pharmadoc and Sharepoint. Self-motivator and strong work ethic.
Jan 2003 - Present
Senior GMP Compliance Specialist
Johnson & Johnson Quality Operations
1997 - 2003
Quality Assurance Manager
CLINICAL TRIAL SERVICES
• Established the quality assurance department to support the clinical processing area.• Developed Standard Operating Procedures, master batch records, change control, trend analysis and training system to comply with regulatory requirements.• Evaluated production, non-conformance, rework, complaint, and validation documentation. • Assessed clinical supply manufacturing, packaging, API, raw material, and labeling documentation to ensure regulatory compliance.• Participated in audits of functions internally and at outside vendors to ensure Good Manufacturing Practices.