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Roberto Rodriguez

Roberto Rodriguez

General Manager

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location of Roberto RodriguezPuerto Rico

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  • Timeline

  • About me

    Quality System Expert at ERCROS

  • Education

    • Inter-American University of Puerto Rico-San Germán Campus

      1993 - 1998
      Bachelor Biology Major in MIcrobology

      Activities and Societies: Member of the Association for Development of Young Scientist, Ronald E McNair; Member of Puerto Rican Federation of Young Scientist Inc; Delegate of the 40th London International Youth Science Forum; Judge for the Regional Scientific Fair; Member of Dr. Ismael Velez History Society, Interamerican University. Ronald E. McNair Program student. Investigation in Medical Mycology

  • Experience

    • Papa Johns

      May 1998 - Dec 2001
      General Manager

      Developed the Papa John’s Pizza Franchise at San Juan, Puerto Rico; establishing nine restaurants on the metropolitan area, creating over 200 employments.

    • Cordis

      Mar 2002 - Feb 2012
      Team Leader - Manufacturing Operator III

      •Participated in a multicultural team in the start-up of Cypher Sirolimus Drug Eluting Stent at Latina, Italy successfully transfer to San Germán, Puerto Rico producing the first coated stent in the market.•Helped on the execution of validation activities for new process to improve production reliability. •Assisted on the generation of the focal point procedure and workshops to increase production yields.

    • RCM Technologies

      Jan 2012 - Dec 2013

      Worked for Zimmer Manufacturing B.V. for Validation Justification Assessment (Remediation Project).Performing validation justification memos. Worked for Zimmer Manufacturing B.V. on Procedure Standardization and Simplification Project (Remediation Project) Revised and audited manufacturing and packaging procedures (developed and performed Quality Plan)Worked for Product Specifications vs. Production Process Control Records (FDA 483 Commitment), Remediation project.

      • Validation Consultant

        Jul 2012 - Dec 2013

      • Senior Consultant

        Jan 2012 - Jun 2012

    • Business Excellence Consulting

      Mar 2013 - Aug 2013
      Validation Expert

      Worked for Integra Lifesciences Añasco, P.R. on a Validation Assessment as a validation reviewer (Stability, Sterilization, Shipping, Equipment and Process Validations) (FDA Warning Letter - Remediation Project)Documented validation addendums for Installation, Operational and Performance Qualifications. Investigations (Generation and Revision), Root cause analysis; and Corrective and Preventive Actions identification and documentation.

    • Labchems

      Dec 2013 - Feb 2014
      Validation Specialist

      Worked for Integra Lifesciences Añasco, P.R. on the Winter Project (design, construction and qualification of new manufacturing areas (facilities) and Equipment installation and qualification) as a validation specialist.Performed protocol executionsDocumented validation protocols, deviations, addendums and reports. Documented Quality Plan Closure Reports.

    • Business Excellence Consulting, Inc. (PR and Spain Divisions)

      Sept 2014 - Sept 2015
      CAPA Investigator

      • Documented and review CAPA investigations.

    • SMITH AND NEPHEW ORTHOPEDICS

      Oct 2015 - Sept 2017
      Quality System and CAPA Supervisor

    • BioPharma Consulting JAD Group

      Dec 2017 - Mar 2019
      CQV consultant

    • ERCROS

      May 2019 - now
      Quality System Expert

  • Licenses & Certifications

    • • ASQ - Certified Biomedical Auditor (CBA) (Medical Devices) - 21 hours Academy

    • • ASQ - Certified Quality Auditor (CQA) - 21 hours Academy

    • • Cardiopulmonary Resuscitation (CPR) (automatic desfrivilator)

    • • Root Cause Analysis, Effective CAPA, and Compliance Writing Workshop

    • • Technical and Compliance Writing for the FDA-Regulated Industry.

    • Yellow Belt Certification