Deborah Rivera, J.D., LSSGB

Experience

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  Ivax Pharmaceuticals

  Jan 2001 - Jan 2004

  Supervisor of 10 chemists from the finish and raw material laboratory. Perform laboratory investigations. Assign daily work plans to the chemists based on the company’s priorities. Data review and batches approvals. Validation reports verification. Laboratory’s samples inventory and disposition. (In process, finish goods, and controlled samples). Laboratory related SOPs writing and training to the chemists. Assurance that the laboratory activities run in a full GMP & GLP environment. Method Optimization Program: Responsible for the execution of Cleaning and Analytical Methodology Transfer Testing, Development of Transfer and Special Study Protocols and Reports, Method Validation Training, and Data verification

  • Finish Product & Raw Material Laboratory Supervisor

    Jan 2003 - Jan 2004

  • Analytical Service Chemist II

    Jan 2001 - Jan 2003
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  Taratec Development Corporation

  Jan 2004 - Jan 2005

  Consultant

  Computer System Validation (CSV) Assessment and Remediation project for business and manufacturing systems. CSV for a Manufacturing Execution System (MES). Writing of URS, Protocols, and Reports Documents. Project Leader for a cleaning method validation project through the last 2.5 months of the project. It included final delivery of all the documents and final wrap-up. Laboratory Cleaning Methods (14) development, optimization, and validation. Writing cleaning method protocols/reports and data review. Show less

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  Watson Pharmaceuticals

  May 2005 - Apr 2006

  Laboratory Supervisor

  Lead, supervise, and workload distribution to Raw Material Area analysts. Increase the group performance by reducing the backlog and human related investigations/deviations. Laboratory representative in company's planning and production meetings and link between QA service areas, production/manufacturing area. Perform weekly metrics for the area performance and Increase group morale by establishing open communication and rewards for all the group accomplishments. Writing the area laboratory investigation/deviations. Show less

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  PepsiCo

  May 2006 - May 2018

  Responsible for the site Non Conformance program including Vendor/Suppliers, Customer Complaints, Product Deviations, Variances, and CAPA. Provide guidance to the site Quality & Operation teams on issue resolution and ensure the efficacy of corrective action plans in accordance with a 6 sigma process. Responsible for the non-conformance metrics generation and lead metric reviews for senior management. Provide Quality support for new supplier’s qualification. Support Technical Services/Procurement Departments on new Business Improvement opportunities Show less Responsible for the laboratory operations to support raw material and finished concentrate approval, 8 direct reports. Compliance assurance of Quality Systems such as NCR, CAPA, Change Control, and Validation. Technical support for out of specification and adjustment of batches for release. Support Corporate and Third Party Quality Audits. Quality Department budget management ($1.865MM). Day to day technical support to the Manufacturing area. Lead and support continuous improvement initiatives. Department’s metric and performance scorecard reporting. Plant’s Trackwise Quality Management System administrator. Material at risk evaluation and monitoring to prevent expiration/rejection. Show less

  • Compliance Sr Supervisor

    Jul 2015 - May 2018

  • Quality Engineer and Vendor Support

    Jan 2012 - Jul 2015

  • QA Supervisor

    May 2006 - Dec 2011
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  JLL

  Sept 2018 - Jan 2022

  Lead Quality System Compliance of JLL at the site. Owner of the Pest Control Program ensuring compliance with company policies, procedures, values, principles, applicable laws, and industry standards. Responsible for the execution and compliance of the Pest Control Service Provider. Manage programs such as Deviations, CAPA, CAPA EV, and Document Management System for JLL team. Provide guidance to JLL team on Quality & Compliance on issue resolution and ensure efficacy of corrective action plans. Generate program execution metrics and lead metric reviews for senior management. Show less

  • GMP Facilities Operations Manager

    Aug 2019 - Jan 2022

  • Quality & Compliance Manager

    Sept 2018 - Aug 2019
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  CSL

  Jan 2022 - now

  • Director, Facilities and Integrated Facilities Management

    Feb 2024 - now

  • Senior Manager, Maintenance Services for Bulk VS (interim)

    Jul 2023 - Feb 2024

  • Maintenance Services, Sr Manager

    Jan 2022 - Feb 2024