Eric Booker

US Mid-Atlantic Region 856-***-**** adua7q@r.postjobfree.com

An extremely talented Document Control Specialist with over ten years’ experience managing document records for highly technical, large vendor engineering and pharmaceutical industries

QUALIFICATIONS SUMMARY

Extensive document and quality control experience on large scale pharmaceutical, chemical, and refining projects with superb attention to detail in a fast-paced environment

Outstanding expediting experience to ensure the timely delivery of materials and equipment to meet project needs for production control, quality control, and project management.

Hands-on approach to team leadership

Exceptional communication and collaboration skills to work with project management teams, vendor contacts, onsite suppliers, and both external and internal clients

Document Control/Business Quality North America Titusville, NJ

Johnson & Johnson Pharmaceutical (Janssen) 05/2022

Managed reference documents from final to retired by obsolete in Veeva Vault. Retiring

doc space number and setting the reason for obsolescence in system

Managed incoming IQ Requests from document authors and initiating documents in route for review Standard

Operating Procedures, Forms, Work Instructions

QC documents for document routing

Managed Target Effective date in Veeva Vault system after training due date received

Retrieve training reports during audits, Transcript Reports, (ITP) Individual Training Plan Report, Learning

Objects Curricula Reports

Associate Document Control Philadelphia, PA 11/2021

Catalent Pharmaceuticals

Reviewed batch records for completeness and ensure any deficiencies identified are fully addressed and investigated as necessary

Review and approve all batch records, where material is packaged and labeled for GMP purposes

Managed and review the GSA scan assembly and packout reports

Associate Document Control Malvern, PA 05/2021

Catalent Pharmaceuticals

Managed GMP documents Vendor Qualification documents, Protocols Reports, IQ/OQ/PQ, SOP, (BMR) Batch Manufacturing Records and Training Records

Maintained Archival of GMP documents for production team

Managed Catalent file room for all site GMP documents

Track and update Catalent Documents in tracking log

Pharmaceutical Document Control Specialist (Remote) Andover, MA 03/2019-06/2019

Pfizer Pharmaceuticals

Managed project documents Drawings, Kickoff Notes, Playbook, Firewall documents and Technical Readiness Assessment documents. Coordinated between multiple engineers and technical writers for Pfizer Cyber Security Project

Maintained input and output of all Cyber Security documents for Project teams.

Managed Pfizer Box Document Management System

Track and update Pfizer Document Tracking Project log

Collaborate a Pfizer Document Control Procedure for all engineers and team members for future Cyber Security Projects

Document Control & Regulatory Compliance Barrington, NJ 10/2018-02/2019

First Pro Inc

Maintained Document Control request for blueprints, drawings and Specifications.

Track, Review & Release Engineering Electronic Change Request (ECN) for Design Services and Research & Development departments using the Global ECN Tool

Managed entering Work Instructions (WI), Drawings, Specs, Test procedures, QAP’s in SAP database

Prepared Sanitized defense drawings for bid

Ensure the activities of other departments involved in releasing and changing controlled documents adhere to procedural requirements

Document Control, Horsham, PA 6/2018-9/2018

Insight Global,

Prepare in document migration from Buzzsaw to BIM 360

Managed consultants-vendors in the northeast region in addition to FL, TX, CO, and AZ with software, procedures, production, effectiveness and administration of projects outsourced to them from Toll Architecture

Managed northeast region outside designer vendor notifications for software application upload

Document Control Specialist, Contractual 2015 – 2017

Johnson & Johnson Pharmaceutical (Janssen)11/2015-2/2016, Iroko Pharmaceuticals,8/2016-12/2016, Genesis Engineering 3/2017-6/2017

Document Control Coordinator for medical devices migration project using Veeva Vault. Ensure tracking of project progress and migration details for Johnson & Johnson. Modification, review and Approval of SOPs, Business Quality Documents, JJRC, Forms, EForms, GMP documents. Collaborated with teams within Janssen organization

Manage Iroko Trial Master File (TMF) records for regulatory, legal, and corporate requirements

Expeditor/Document Control for Phase II Integra Pharmaceutical project at Genesis Engineering. Managed vendor submittals and deliverables to site

Document Control Specialist, Jacobs, Conshohocken, PA 2006 – 2015

Managed and maintained Document Management System Database including configuring database functionality that met project and ISO 9000 documentation requirements

Team Lead for Novartis pharmaceutical project in Holly Springs, NC

Input documentation request, information and track documentation fulfillment

Serve as primary point of contact support for Project Management Team

Example large-scale vendor responsibility for implementing document control activities

Delivered training necessary to establish and operate the control of records for specific accounts and maintained yearly retention, storage, and destruction of records

DuPont, Wilmington, DE. $100M Chemical Project

Genzyme/Sanofi, Allston Landing, MA. $250M Bio-Pharmaceutical Project

Amgen, Juncos, PR. $150M Pharmaceutical Project

Novartis, Holly Springs, NC, $300M Pharmaceutical Project

Amtrak, Philadelphia, Baltimore MD, Richmond VA.560M Infrastructure Project

Confidential Client, Yanbu, Saudi Arabia. $1 billion-Power Plant Expansion

Technical Information Coordinator, Shaw Stone & Webster, NJ 2005 – 2006

Managed document project correspondence, design, vendor, and technical documentation

Maintained logs for tracking of design documents for client review, approval, and distribution and generated reports via Documentum

TECHNICAL SKILLS

Microsoft Office Suite, Word, Access Database, PowerPoint, Xerox 8830 Digital Document System, GMP, Documentum, Box Document Management System (Cloud Content Management), Adobe Acrobat Professional, Bluebeam, SAP, SharePoint 2010, Tru Vault, BIM 360 Team(Autodesk), Vault 2017(Professional) Buzzsaw 2013(Autodesk)

EDUCATION

Union College, Scotch Plains, NJ 1990 – 1992

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