Quality

SUMMARY

Seasoned Quality professional with significant management experience in Quality Assurance and Validation for domestic and international sites. Developed and implemented numerous programs including ISO, ICH, HAACP and cGMPs. Creative problem solver with in depth project management, auditing and risk assessment experience.

PROFESSIONAL EXPERIENCE

Aerotek - Cincinnati, OH 06/2008 – 11/2008

HACCP Consultant

Reviewed and assessed a major consumer product for company’s existing HACCP program. Delivered a final report, with specific recommendations for enhancing the program, which would enable it to meet the requirements for certification. Client: Proctor and Gamble.

Alkermes, Inc. - Wilmington, OH 08/2005 – 05/2008

Develops innovative medicines that fit with patients' real-world needs and behaviors.

QA Manager, Validation

Manage site validation activities and personnel in aseptic and sterile environments.

• Successfully managed the validation, including utilities, equipment, cleaning and process of a new production line and provided in depth support to the launch for final drug approval.

• Managed the site validation operations, encompassing the areas of manufacturing, filling, laboratory and utilities, which received no major findings during customer audits and regulatory inspections (US, EU, and Japan).

• Generated regulatory filings working with Regulatory group.

• Supported Clinical projects for drug development.

• Developed and enhanced validation and compliance programs for drug development from clinical to commercialization.

• Lead Change Control and provided guidance to various QA activities, including deviations, CAPA’s and investigations.

• Resolved numerous production related problems, involving material compatibility, flow issues and equipment failure.

QVM SERVICES, L.L.C. - Kansas City, MO 07/2003 – 07/2005

Specializes in providing Quality Management Systems Implementation, Regulatory Support, Commissioning, Qualification and Validation Services and Training Programs to pharmaceutical, biotechnology and medical device firms nationwide.

Project/Validation Manager

Manage Validation and Quality projects and personnel.

• Effectively managed validation teams at five client sites, receiving positive feedback from each client for team’s outstanding performance.

• Provide guidance to clients in developing and implementing their cGMP including ICH, ISO, Quality Management Systems and Quality Assurance programs, ensuring successful audits from customers and regulatory agencies.

• Assisted clients with the various activities; Change Control, CAPA’s, deviations and investigations.

• Provided support with regulatory filing and documentation generation.

• Clients include; Pfizer Kalamazoo, Pfizer Lincoln, Weyth Pearl River, Afton Scientific

Independent Consultant - Apple Valley, CA 2001 – 2003

Project Manager

• Developed and strengthened Quality programs to ensure compliance to ISO or cGMP including ICH, requirements.

• Performed pre-audits for cGMP and HACCP programs to identify and correct deficiencies prior to scheduled customer audits.

OMYA 1994 - 2001

OMYA Arizona, Inc - Superior, AZ

Manager of Quality Assurance and Regulatory Affairs

Managed quality and regulatory affairs department and personnel.

• Ensured the design and construction activities of new Pharmaceutical plant met the quality and validation requirements.

• Managed all company quality functions, including serving as management representative with regulatory agencies (FDA, EU).

• Developed, implemented and managed ISO 9000, HACCP, Kosher, cGMP programs and validation activities.

• Responsibilities included managing; change control, customer complaints, CAPA’s, deviations, investigations, product release, SOP and Batch Record systems.

OMYA (California), Inc. - Lucerne Valley, CA

Quality/Technical Manager

Managed Quality Assurance/Control, Information Technology and Automation Departments and Personnel.

• Provided programming support which contributed to a successful on-time startup of new production line, and managed product qualification.

• Developed, implemented and managed ISO 9000, HACCP, Kosher and cGMP Programs.

• Responsibilities included managing; change control, customer complaints, CAPA’s, deviations, investigations, product release, SOP and Batch Record systems.

• Certified as an ISO Lead Assessor.

Independent Consultant. - Apple Valley, CA 1992 - 1994

• Provided Advanced Materials Engineering and Information Technology services to private sector and defense industry clients.

General Dynamics Advanced Missile Systems - Rancho Cucamonga, CA 1989 – 1992

Senior Research Engineer – Advanced Materials

• Lead research and development for missile and defense programs, resulting in a patent for new warhead design.

• Provided Quality Assurance support for various defense programs.

Aerospace Corporation - El Segundo, CA 1980 - 1989

Research Associate – Materials Technology/Program Office

• Conducted research and development in Advanced Materials for space and defense programs, resulting in two application patents.

• Provided Quality Assurance support to numerous program offices, including Space Shuttle program.

PROFESSIONAL DEVELOPMENT

Parenteral Drug Association, member

ISO Lead Assessor

Total Quality Management

Design of Experiment – Concurrent Engineering

EDUCATIONAL PROFILE

University of California, Los Angeles

Materials Science Engineering

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