Document Management Change Control

Virgil Raymundo

Brandywine Rd. Fords, NJ ***** (CP) 917-***-**** e-mail ad8yq2@r.postjobfree.com

Professional Summary

Broad knowledge of Veeva Vault application

Change Control Impact Assessor

Good understanding of Software Development Life Cycle (SDLC) and Electronic Document Management Systems (EDMS)

Extensive background GEODE+ (Documentum), Le@rn, TrackWise and DCN (Document Change Notice)

Excellent experience in a world class and FDA monitored manufacturing facility Thorough knowledge of cGMPs/FDA policies and guidelines.

Extensive background of maintaining and coordinating Quality systems related documents

Excellent experience in data collection, auditing batch records and process validation

SAP (Systems Application for Data Processing) inventory

Skills - Work History

Sr. Documentation Administration Specialist 01/2020 – Present

BMS/hCelgene – Summit, NJ

Part of the Change Control Regulatory Board (CCRB). Impact Assessor of the QA Engineering functional areas for change control. Coordinates GxP document management activities to support local as well as global internal business partners. Responsible for the following daily documentation related activities: creation/edit/, review/approval, effectuation, obsolescence, and archival. Provided guidance to document authors, ensuring documents are created/edited per current governance procedures and all compliance requirements for format, content, standardization, and periodic review are met. Supports periodic document review processing and metrics reporting. Identifies trends and escalates accordingly. Approves Celdox user access requests for system roles with elevated privileges, including access to restricted groups. Revises documentation owned by the Documentation department (system and process). Leads Celdox Editor/Owner instructor-led training as a qualified Celdox trainer. Participates in improvement projects for the documentation system and process governance. Serves as Veeva Quality Docs SME and provides guidance to Celdox users as needed. Supports document management harmonization and integration efforts between Celgene and BMS. Supports daily operation of the NJ site physical records room, including physical records issuance, archival charge-in, charge-out, and reconciliation. Processed records identified for offsite storage at Iron Mountain or transfer to/from site due to site internal closures, divestitures, and acquisitions. Supports physical or electronic records retrieval for site audits.

Document Management Coordinator 07/2019 - 12/2019

Johnson and Johnson – Route 22, Bridgewater, NJ

Communicated effectively with all cross functional and regional stakeholders on matter related to documentation process and systems. Supports daily operation of the NJ site physical records room, including physical records issuance, archival charge-in, charge-out, and reconciliation. Processed records identified for offsite storage at Iron Mountain or transfer to/from site due to site internal closures, divestitures, and acquisitions. Supports physical or electronic records retrieval for site audits. Also, supports improvement projects for the physical records room. Revised documentation owned by the documentation department (system and process).

Documentation Specialist II, Quality Documentation and Training 07/2017 – 06/2019

Sanofi - 55 Corporate Dr. Bridgewater, NJ

Documentation manager of electronic system used for quality functions namely GEODE+ (Documentum) and Le@rn system. Worked with the functional groups in North America business operations to create/revise Quality Documents representing North America (US & CA). Provided support in Quality document migration activity. Reviews new and existing Quality Documents for compliance to Sanofi policies, directives and procedures as required. Engaged with stakeholders to migrate and manage the Quality documents across Business units. Assisted with the editing of quality documents (SOP’s, guidelines, validation master plans, etc.) to ensure compliance with regulatory requirements. Worked quickly with a high degree of accuracy. Able to relate well to others at all levels throughout the organization and can work in a team environment, effectively interacting with others. Maintained the Training Curriculum for North America. Served as the primary support for the management of training and tracking through the Learning Management System for North America. Managed learner profiles of US and Canada within the Le@rn system.

Senior Quality System Specialist 02/2013 – 02/2017 Renaissance Lakewood, LLC Airport Rd. Lakewood, NJ

Acted as administrator of electronic system used for quality functions namely Documentum, DCN (Document Change Notice) and e-infotree system. Provided training to newly hired personnel to ensure effective use of the system. Generate workflows for periodic review, creation, revisions, review, approval and implementation of procedures, forms, batch records, method using electronic system as documentation. Maintained and coordinate quality systems related documents namely batch records, Change Controls, and deviations for compliance with cGMP and company procedures with minimal supervision. Reviewed and wrote cGMP procedures under supervision. Maintained and report Quality metrics and trending of data. Performed gap analysis of all quality related procedures to ensure there are no gaps present. Assisted document retrievals during audits. Interact with department and customers to ensure timely revisions and corrections of the documents needed for release. Completing actions in Trackwise.

Quality Control Specialist II Contract through Aerotek 02/2010 – 02/2013 Tandem Labs CRO – West Trenton, NJ

Conducting reviews of data tables for accuracy against Watson and for correct formatting. Reviewing sample receipt, solutions and QC sample preparation documentation, run folders and other laboratory documentation for accuracy and adherence to SOPs, GLP guidelines and established laboratory policies as directed. Worked closely with project manager in reporting all study results.

Quality Assurance Batch Record Auditor 07/2004 – 06/2008 Alpharma Pharmaceutical Elizabeth, NJ

Audited manufacturing, packaging, laboratory, and validation batch records. Worked with R&D personnel regarding new products, reviewing new product development and batch records. Reviewed all stability sample results from the laboratory to make sure that the results comply. Reviewed calibration records determine compliance with specifications.

Education

Lyceum of the Philippines (Diploma)

Bachelors in science of Biology

Microsoft Windows and Excel Certification

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