Izora12@yahoo.com

Change control administrator, Quality Assurance function and proof reader of scientific protocols, SOP's, revisions, and investigator reports in electronic data management system Adaptive. Responsible for all document control functions, including initial document login, tracking, processing, final distribution and archival of GMP documents.

Electronic Document Management

Systems (EDMS Documentum, Adaptive and Celldocs). Adhered to company business practices and FDA guidelines to ensure compliance with GMP Standards and related Work Instructions and Standard Operation Procedures. Prior experience in compiling design history file for FDA pre-submission audits.

Prior case management experience in compliance and quality assurance management, at New Jersey Organ and Tissue Sharing Network. QA review of donor medical recover documentations, autopsy records and case management files. Prior experience process engineering as Sr.

Laboratory

Technician in Biological Services and Process Engineering. 10 plus years utilizing various validated Quality data Management system including Adaptive, Cell Docs, SAP and Risk management system (IVR).

Documentation Author / Quality Assurance Specialist - Bristol Myers Squibb - New Brunswick, New Jersey, United States

(2022-04 - 2022-08)

• Ensure project leads include documentation and training timelines to project plan
• Support the revision and creation of the documentation that includes, but not limited to, issuance of documentation template, formatting, verify references, history and scope, routing for review and approval in accordance with BMS procedural document process. Manage documentation and training periodic review
• Perform documentation impact assessment
• Review training plans, identify curricula and send to Training Specialist for Success Factors up load
• Ensure document is released with effective date and sufficient training period for document release date. Documentation Reviewer per document data system Documentum, proficient in Microsoft Office 365 (Word, Excel), and SharePoint, and learning management systems (LMS).

Quality Assurance Documentation Specialist III - Sanofi - Bridgewater, New Jersey, United States

(2019-04 - 2019-08)

Worked within the scope of Quality Documentation and Training Operations Program to provide support for the operation and maintenance of the Quality Document Management and Training process within North America Quality (NAQ). Prior experience utilizing SharePoint for grouping working documents for review. Strong understanding of quality document management systems and the pharmaceutical industry.

• Aids and assisted in the daily management of various Quality Assurance and Training operational functions
• Work with the functional groups in North America Business Operations to create/revise Quality Documents Representing North America (US & Canada)
• Support the operation and maintenance of the Quality Document Operations Master Data
• Engage with stakeholders to migrate and manage Quality Documents across Business units. Assist with the editing of quality documents (SOP's, guidelines, validation master plans, etc.) to ensure compliance with regulatory requirements
• Engage with stakeholders to align local Quality Documents with Global policies and guidelines
• Manages the user access requests for the quality document management system rights Maintains a constant state of sustainable compliance and inspection readiness for all activities related to the Training and Quality Document Functions including, but not limited to, lifecycle management of Quality Documents, accuracy of training curricula, and CV/JD's for areas of scope.
• Generates reports from the Learning Management System and provide compliance reports as needed during Audits, monitoring and routine oversight activities

Document Change Control Specialist - Ethicon Medical Devices and Diagnostics Pharmaceutical, a Johnson & Johnson Company - Somerville, New Jersey, United States

(2017-03 - 2017-06)

• Responsible for auditing, review, updating Drug Master File and data management system (ADAPTIVE) according to GLP guidelines for FDA inspection.

Document Change Control Specialist - Ethicon Medical Devices and Diagnostics Pharmaceutical, a Johnson & Johnson Company - Somerville, New Jersey, United States

(2013-08 - 2014-06)

Principal Duties and Responsibilities for Ethicon North American

• Change control documents and data analysis on scientific documents Coordinate revision, review and approval of all GMP documents.
• Provided training support to scientific staff on data management system uses and functions
• Analyzed creation of new document and revisions to existing SOP's Scientific Procedures and Drawings
• Labels
• Verified that all existing procedures affected by the change have been followed per governing change control procedures. Maintained and worked with Global CMC regulatory guidelines.
• Resolved deficiencies, inconsistencies and discrepancies in documentation identified for change and reviewed change documentation for completeness and accuracy, including all aspects of the Change Order (CO) process. Interfaced with QA organization and the Ethicon user community, primarily Change Owners for managing changes to controlled documents.
• Verified and ensured that the proposed change is compiled, prepared, reviewed and approved per established procedures and aligned with relevant regulations. Data system used: Adaptive, SharePoint, MS Office (Excel, Word).

Document Control Specialist - McNeil Consumer Pharmaceuticals, a Johnson & Johnson Company - Fort Washington, Pennsylvania, United States

(2013-03 - 2013-08)

• Responsible for review and processing of change control documentation and Master Data to ensure compliance with company SOP and procedures.
• Responsible for working with internal and external subject matter experts to gather relevant information to effectively support the change control process.
• Trained scientific staff on data management system use and functions.
• Timely implementation and closure of change controls while ensuring compliance to applicable quality standards and change control procedures.
• Administrator responsibilities of electronic data management system and process metrics

(2023-01 - 2024-12)

Personal leave of absence (LOA)

BA - Communications - Rutgers University

AS - Essex County College

AS - Chemical Technology