Ivette Rivera

Experience

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  Patheon

  Aug 2011 - Mar 2014

  • Inspect and approve the process of Manufacturing and Packaging stages. • Audit of Batch Records, Chemical Results and related documents to assurance compliance with established Standard Operating Procedures (SOP’s), client requirements and cGMP’s.• Respond to operational events, Deviations, Start-up, Change control, CAPA, Validation protocols and external audits.• Responsible for Certificate of Compliance generation and lot release process, including releases strategies.• Approve the batch and analytical results in LIMS, TrackWise and Fourth Shift systems.• Internal audits to production and warehouse areas.• Support with client Requests. Show less

  • QA

    Dec 2011 - Mar 2014

  • Manufacaturing

    Aug 2011 - Jan 2012
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  AbbVie

  Jan 2014 - Jul 2015

  Cleaning Validation Engineer

  • Write and execute cleaning process validation protocols, engineering studies and final reports for cleaning protocols of manufacturing equipment. • Perform cleaning verification swabbing. • Compile data summaries on the results of sample testing. • Develop cleaning procedure for cleaning manufacturing equipment.

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  Edwards lifesciences

  Jul 2015 - Jun 2016

  • Provide guidance and support for Concord Process Validation activities including developing Test Method Validation (TMV) protocols and Tool Fixture Installation Qualification (TFIQ) for Master Validation Remediation Project. • Collaborate with production to develop validation plans, TFIQ, FAI and TMV protocols; analyze data, and the effectiveness of the quality management system validation process. • Monitor process validation processes and TMVs to ensure strict accordance with product and process specifications.• Author protocols, execute protocols, and summarize validation studies with an emphasis on validating test methods used to verify the conformance of received materials and /or components. Work with manager and team to maintain validation planning and appropriate progress towards completion of validation work. Write scientifically valid protocols using sound scientific rationales for experimental design and data collection for validation studies. Show less

  • Materials Engineer

    Feb 2016 - Jun 2016

  • Process Validation Engineer

    Jul 2015 - Feb 2016
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  Business Excellence Consulting

  Jun 2016 - now

  Remediation Specialist

  •Work in developing a quality remediation plan to close the observations from a FDA warning letter. Understand how to resolve the issue by evaluating the specific observation and expanding any evaluation to similar systems, processes, and/or products. •Validation Maintenance Reviews •Revise and review SOPs, validation requirements related to validation/revalidation activities.•Ensure and/or executed proper maintenance of test equipment used for validation/ revalidation.•Conduct evaluations to ensure equipment state validated. Show less