Document Control Management

Emma Fernandez

San Jose, CA *****

Phone: 408-***-****

ad0uzf@r.postjobfree.com

EXPERIENCE:

Document Control Specials

Johnson & Johnson Vision 2019 to Present

Milpitas, CA

Experience with implementing and maintaining product lifecycle process such as BOM management ECR, ECO, MCO, TCO and deviation processes in a production environment.

Implement version control procedures to track document changes, updates, and revisions as well as requests for revisions. Ensure that the latest versions of documents are readily available to authorized personnel

Support archiving of records stored in Document Control and coordinate movement to offsite storage

Coordinates the distribution of documents to the relevanct deparments and individuals ensuring that the appropriate stakeholders have access to the information they need.

Verify and ensure the accuracy of ECO documentation, part numbers, drawing revisions, spec sheets, and vendor part number cross-references.

Create part numbers, BOMs, product configurations, and manage item master data in the Document Management System

Initiate, process, route, and distribute ECOs with guidance from process owners and engineers.

Identify opportunities to streamline document management processes, improve documentation practices and enhance overall quality control procedures.

Support update, review and approval of controlled documents, including standard operating procedures, protocols, reports and technical documents according to specific approved formats

Initiate and track all incoming, in-process and completed document change requests, associated supporting documentation and following up to ensure the changes are completed and documentation is properly closed out and released.

Provide guidance on document control practices and procedures to all functional departments

Handles special projects requests as assigned by Team Lead or Manager

Maintain the Document Control database, log files, and storage of Engineering drawings.

Experienced SAP supporting Material Master setup, Agile PLM, and MS Office Excel

Document Control Specialist

ABBOTT, Santa Clara, Ca. 2003-November 2019

Maintains the update, review, release, and storage, of all controlled documents and maintain EDMS. Documents may include, but are not limited to policies, work instructions/processes, standard operating procedures (SOPs), forms, templates and IFU's (Instructions for Use)Tracked change orders through change order process, ensured changes were approved and documents were updated before release, archived older revisions of documents

Reviews quality records and related documentation for compliance with operating procedures, protocols, work instructions, etc

Retrieved and stored historical information at retention archives as requested

Managing the configuration, daily administration and monitoring of the electronic Document Management and Training System

Assisting in preparation, implementation and validation of upgrades and improvements for the electronic Document Management and Training System. Ensuring quality-oriented and efficient turnaround of documentation and Quality Event tasks, including review for compliance to internal procedures and formatting standards. Issuance of document change control numbers, routing and tracking of new and revised documents for approval, filing of controlled documents and other documentation provided to QA, and ensuring that all documents follow the change control procedure

Assist in quality audits, including document preparation and record retrieval

Verify and ensure the accuracy of ECO documentation, part numbers, drawing revision, spec sheets for commercial parts, cross reference to vendor part numbers, etc

Create part numbers, BOMs, product configurations and manage item master data in a Document Management System and interface seamlessly with production

Initiate, process, route and distribute Engineering Change Orders with direction from process owners and engineers.

Monitoring of status of in-process document changes to ensure timely completion. Manage the Electronic Document Management System (EDMS) activities as assigned

R & D ENGINEERING TECH COORDINATOR

SANMINA CORP San Jose, Ca. 1998-2003

●Calibrated of all equipment in R & D lab

●Collected data from production test equipment in various departments

●Assisted Quality Department with RMA Analysis and Test verification

EDUCATION:

Heald College

●Associates Degree

UCSC, Santa Clara, Ca

●Data Management Plan

Silicon Valley College, San Jose, Ca

●Administrative Medical Assistant and Billing and Coding

SKILLS:

Strong customer focus and self motivated

Proven flexibility and adaptability

High level of accuracy and attention to detail

Able to prioritize and manage own workload independently

Demonstrate ability to maintain a working knowledge of GCPs and SOPs

Computer Skills: Oracle database, CART, eCRFs, Microsoft Office, EDMS, Windchill, Agile, SAP, TruVault

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