Marilyn Guerrero
Ocean Gate,NJ
Summary
Dynamic Quality Management professional with extensive experience in optimizing Change Control systems and ensuring compliance with GxP regulations. Proven track record in leading the transition to electronic documentation systems and enhancing operational efficiency through process improvements.
Overview
1
1
Certification
36
36
years of professional experience
Work History
Manager, Quality Management Systems
Amicus Therapeutics
01.2022 - Current
- Manage, maintain, and continuously improve the Change Control system (paper or electronic).
- Optimized and maintained change control procedures and training materials for key stakeholders, enhancing compliance and understanding.
- Compiled monthly metrics on Change Control system to facilitate management decision-making, audits, and health authority inspections.
- Maintain and retrieve Change Control documentation to support health authority inspections and/or audits.
- Manage the record retention process and archive (Iron Mountain etc.) and supporting procedures.
- Lead the implementation of the electronic system processes as it relates to user requirements, UAT, implementation and training that includes training materials.
- Supported activities related to changes, enhancements, and upgrades for electronic systems, ensuring alignment with user requirements and regulatory standards.
- Support Document Management lifecycle activities, upgrades/releases, and projects as needed.
- Support Quality Management Systems as needed or project activities.
Senior Associate, Quality Management Systems (Change Control, Document Management)
Amicus Therapeutics
01.2017 - 12.2021
- Lead weekly global Change Control Review Board (CCRB) meetings for alignment of changes cross-functionally with key stakeholders.
- Manage the global Change Control system to ensure all proposed changes adhere to companywide policies/procedures and GxP regulations.
- Lead the transition of the Change Control paper-based process to electronic solution (e.g.: Trackwise Digital).
- Support implementation of electronic Trackwise System process as it relates to user requirements, UAT, implementation and training.
- Support ongoing activities related to changes/enhancements and upgrades with Trackwise System for Quality Events, Investigation & CAPA.
- Implemented process improvement for minor and major change control that resulted in a reduction of cycle time.
- Maintain procedures and process flows and provide guidance to business owners to ensure alignment and consistency of change.
- Represent the change control program in internal/external audits and regulatory requirements for clinical and commercial products developed and marketed by Amicus.
- Developed and reported monthly and quarterly metrics for change control and document management, facilitating monitoring of QMS system and informing management review.
- Administer and maintain the electronic Document Management System, specifically document management lifecycle and document business contingency for a global organization.
- Supported archive and inspection readiness for health authority inspections.
Quality Assurance Associate (Change Control Coordinator)
Renaissance/ Meda Laboratories
01.2014 - 12.2017
- Managed Change Control process, organized Change Control Review Board meetings, and collaborated with clients to secure timely approval of changes.
- Developed, routed, and implemented QIS Standards for MUSE product to ensure compliance and quality assurance.
- Reviewed, routed and implemented Material Specifications for MUSE product.
- Coordinated the creation of specifications in conjunction with project management to support production schedule.
- Led quality initiatives for new product introductions, ensuring specifications, change controls, and procedures were effectively implemented for successful product launches.
- Revised, reviewed, approved and Issued batch records to meet production needs.
- Created, routed and closed out Project Records in Trackwise for MUSE artwork.
- Assigned and routed electronic Document Control Notifications, ensuring timely processing.
- Routed and released procedures in Documentum to support company projects as needed.
- Assumed additional responsibilities during staffing transition as an Interim incoming inspector, while maintaining existing responsibilities, until the inspector was replaced.
- Evaluated incoming raw materials to ensure compliance with specifications and packaging components. Raw material was weighed and sampled.
- Visual inspection, measurements and quantity verifications were performed on packaging components to ensure they were within specification.
- Reviewed commercial BOMs for accuracy in ERP system. Communicated and resolved discrepancies.
- Authored and routed procedures in Documentum to support daily responsibilities.
- Member of company Communications Group to present improvements and ideas to management.
Quality Assurance Specialist
Meda/VIVUS, Inc.
Lakewood, NJ
01.2011 - 12.2014
- Oversaw global Change Control system, ensuring compliance of proposed changes with company policies and GxP regulations.
- Assisted in the implementation of the Change Control electronic system, TrackWise.
- Tracked key quality projects to closure, coordinating with departments to ensure timely completion.
- Acted as a resource for department and peers in resolving QA issues.
- Facilitated internal audits by creating agendas, interviewing SMEs, and reviewing processes to confirm adherence to procedures.
- Documented findings during Health Authority Inspections to ensure compliance. for Health Authority Inspections (i.e.: FDA, MIIRA etc.).
- Prepared statistical information for all commercial annual product reviews.
- Held bi-weekly meetings with change owners and stakeholders to discuss the status of open changes.
- Managed the document lifecycle for procedures in the organization.
Senior Document Control Specialist
Meda/VIVUS, Inc.
Lakewood, NJ
01.2008 - 12.2011
- Led Quality Document Control department operations to ensure compliance and efficiency.
- Coordinated and prioritized incoming documentation changes to streamline workflow.
- Provided key Quality Metrics for Management review.
- Assigned lot numbers and issued batch records for manufacturing.
- Conducted SOP Review Meetings to ensure alignment to templates and functions.
- Developed, implemented and maintained GxP archive system for the company.
- Participated on Project Teams as Document Control representative.
Documentation Processor/Document Control Specialist
Meda/VIVUS, Inc.
01.1999 - 12.2008
- Developed a system for processing and tracking of controlled documents.
- Maintained documentation-filing system, ensuring compliance with approved procedures and global Health Authority regulations.
- Assisted in transitioning from a paper-based system to eDMS, NextDocs, enhancing document accessibility and management.
- Created online folders for each phase of the process and created spreadsheets to track the progress of the document.
- Provided clerical and administrative support for corporate document control center, ensuring efficient document management.
QA Auditor/Production Auditor
01.1997 - 12.1999
- Responsibilities included auditing batch records at all stages for completeness and accuracy for submission to management.
- Conducted product reconciliation of clinical or commercial production supplies and communicated discrepancies to manufacturing lead for resolution.
- Investigated discrepancies and incomplete reports, analyzed material usage and production results for trends, bill of material accuracy, and improvement opportunities.
Production Supervisor
Paco Pharmaceuticals
Lakewood, NJ
01.1991 - 12.1997
- Managed operation of assigned production activities, ensuring compliance with all relevant SOPs.
- Ensured availability and adherence to specifications in compliance with cGMP.
- Provided personnel training and line guidance to enhance production performance.
Machine Operator / Line Leader
Paco Pharmaceuticals
Lakewood, NJ
01.1991 - 12.1997
- Inspected phases of line production, disassembled, reassembled, and sanitized machines, ordered and staged raw materials to maintain production flow.
- Led daily operations of ten employees, fostering collaboration and ensuring team met production targets.
- Operated machinery for production of pharmaceutical products.
- Monitored equipment performance and maintained quality standards.
- Conducted routine inspections to ensure safety compliance.
Education
Certificate - Introduction to Human Services, Communication Skills for the Iluman Services Professional
University of Phoenix
Remote 01-2011
Associate of Applied Science -
Ocean County College
Toms River, NJ01-2010
Custom Excel 97, GroupWise 5.2, Intermediate Access 97, Beginning Access 97, Advanced Word 97, Word 2000 Level 3
CTI Computer School
Lakehurst, NJ01-2002
Skills
- Change Control Management
- Document Management
- TrackWise Digital
- Veeva Vault Quality Suite (All)
- MasterControl eQMS
- SAP ERP
- Outlook, Excel, Power BI, Teams, SharePoint)
- Electronic Quality Management Systems (eQMS)
- Document Management Systems (Documentum, NextDocs)
- Data Analytics & KPI Dashboarding (Power BI, Excel)
- Quality System Auditing
Certification
- Notary Public, New Jersey
- CPR/First Responder
- Mental Health First Aider
Timeline
Manager, Quality Management Systems
Amicus Therapeutics
01.2022 - Current
Senior Associate, Quality Management Systems (Change Control, Document Management)
Amicus Therapeutics
01.2017 - 12.2021
Quality Assurance Associate (Change Control Coordinator)
Renaissance/ Meda Laboratories
01.2014 - 12.2017
Quality Assurance Specialist
Meda/VIVUS, Inc.
01.2011 - 12.2014
Senior Document Control Specialist
Meda/VIVUS, Inc.
01.2008 - 12.2011
Documentation Processor/Document Control Specialist
Meda/VIVUS, Inc.
01.1999 - 12.2008
QA Auditor/Production Auditor
01.1997 - 12.1999
Production Supervisor
Paco Pharmaceuticals
01.1991 - 12.1997
Machine Operator / Line Leader
Paco Pharmaceuticals
01.1991 - 12.1997
Certificate - Introduction to Human Services, Communication Skills for the Iluman Services Professional
University of Phoenix
Associate of Applied Science -
Ocean County College
Custom Excel 97, GroupWise 5.2, Intermediate Access 97, Beginning Access 97, Advanced Word 97, Word 2000 Level 3
CTI Computer School