Ricardo Guzman CQA

Experience

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  Mova

  Jul 1996 - May 1997

  Microbiology Laboratory Analyst
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  Amgen

  May 1997 - Jan 2001

  Responsible for the Computerized Environmental Monitoring System and all of the documentation that was generated from it. Responsible for investigating any situation that might affect the environmental conditions of the manufacturing areas. Was directly involved in all the validations, calibrations, and preventive maintenance of all the parts of the system, as well as the development and/or revision of procedures dealing with the system, and the environment of the manufacturing areas. Worked in the qualification of new manufacturing areas and of operations in the existing areas. Trained the plant personnel in aseptic techniques, and on any regulation that addressed the environmental conditions of the areas. Show less

  • EMS Coordinator

    Aug 1998 - Jan 2001

  • Manufacturing Associate

    Dec 1997 - Aug 1998

  • In Process QA Auditor

    May 1997 - Dec 1997
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  Schering-Plough Kenilworth

  Jan 2001 - Mar 2001

  In Process QC Supervisor
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  Ayerst-Wyeth Pharmaceuticals Incorporated

  May 2001 - Mar 2003

  Product Coordinator

  Audit and verification of the manufacturing processes and documentation generated during the complete production cycle. Revise and approve all related documentation for Raw Materials, Components, Intermediate and Finished Products. Verify that all documentation complies with cGMPs, Corporate Guidelines, Specifications, and applicable SOPs.Identify, document, notify, and follow up on Non-Conformances and Events found. Responsible for assigning final disposition to product lots in the parenteral plant.Perform data gathering and analysis for QA metrics, lot status reports and Annual Product ReviewsServe as a liaison between the Quality Assurance organization and Customer Services, Manufacturing, Packaging Departments, Laboratories and third party contractors. Show less

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  Eli Lilly and Company

  Mar 2003 - Jan 2005

  Packaging Area QA Representative

  Audit and verification of the packaging processes and documentation generated during the complete finishing cycle according to cGMPs, Corporate Policies, applicable SOPs, and all the regulations that apply to each particular product, market and client.Investigated complaints received for Dry products manufactured at the PR1 Plant following all applicable company policies and government regulations. Responsible for assigning final disposition to product lots in the solid dosage plant and complying with the supply chain schedules and requirements.Evaluate and approve procedures, investigations, complaints, change controls, and validation protocols related to existing as well as new products. Show less

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  Eli Lilly and Company

  Mar 2005 - Mar 2006

  Clean Utilities /Mfg QA Rep
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  Eli Lilly and Company

  Dec 2006 - Sept 2011

  Evaluate and approve area procedures, deviations, change controls, and validation protocols related to all the GMP utilities serving the plant. These include two (2) water systems, environmental monitoring, and compressed air serving the production and laboratory areas at PR01.In charge of the five technicians performing the sampling and monitoring of the plant's GMP utilities.Involved in all the changes, validations, calibrations, and preventive maintenance performed on the utilities systems, as well as the development and/or revision of procedures. Show less

  • Global LIMS Implementation QA Representative

    Feb 2010 - Sept 2011

  • Clean Utilities QA Representative

    Dec 2006 - Sept 2010
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  Amgen

  Sept 2011 - now

  • External Supply Quality Manager

    Jun 2020 - now

  • Plant QA Manager

    Sept 2014 - Jun 2020

  • QA Specialist

    Sept 2011 - Sept 2014