Jonathan Sample

Jonathan Sample

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 History

Work History
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.

Education

Education
1993 - 1997

Bachelor of Science

University of Southern California

Skills

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