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Summary

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.

Work experience

Jan 2003Present

Senior GMP Compliance Specialist

Johnson & Johnson Quality Operations
19972003

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.

Education

19931997

Bachelor of Science

University of Southern California

References

Deborah Bernstein

Jonathan is a deep and broad thinker, exemplary qualities needed in a successful strategist. His grasp of complex issues informing strategic campaigns is rapid yet profound.I have helped inform his digital strategic teams on scientific issues, working together to provide client strategic direction, and always found her quick assimilation of information and integration of facts to be remarkable. He is hard working, creative and self-motivated, and it is a joy to work together.

Portfolio

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Skills

FDA Management and Compliance
Provided expertise in FDA management, investigation and compliance, medical device compliance inspection, drug manufacturing compliance investigation, biotech assessment auditing, forensic analysis, expert testimony, and related expertise to a wide variety of applications.
Computer and Quality Applications
Visio, Microsoft Project, Minitab, SPC, Six Sigma, PDM, SDMS, LIMS, LMS (Learning Management System) and Track Wise.
Project Management
Quality Management Systems Chemistry Manufacturing and Controls Global Drug Stability Program Training and  Development  Corporate Audit