Document Control Auto Cad
Resume:
Gary Simpson
Extensive experience working as Document Control Specialist working with Spreadsheets, Excel files, engineering files, medical device documents & Government Supply invoices; experienced as an Auto Cad Drafter and Technical Illustrator on Auto cad 14 2000 thru 2015 versions. Trained in SAP, Agile, Cimage, Webcor, Documentum, Crystal Reports, Altiris, Oracle, SharePoint, Master Control, Made to Manage, Koufax documents, Bartender software, Adobe Illustrator, Photoshop, and Solid works software. Worked in QA departments auditing Word Documents, Solid Works drawing, Auto Cad Drawings revving documents in Oracle, SAP and Agile.
Skills:
•
• Document Control
• Excel Spreadsheets
• EDMS
• PLM System
• Koufax documents
• SAP
• Agile
• Cimage
• Webcor
• Documentum
• Crystal Reports
• Altiris
• Oracle
• SharePoint
• Master Control
• MS Office Suites
• Adobe Illustrator
• AutoCAD
• Photoshop
• Solid works software.
• Attention to Detail
Professional Experience:
Fate Therapeutics Inc, San Diego, CA
Contract Document Control &Training Assistant ~ Quality Assurance OCT 2023 – to present.
• Maintaining the various document type that the company use for the training and manufacturing their product. These include QJT records, Logbooks, Batch Record, Deviation and CAPA Documents etc.
• I was task with creating and reviewing final production labels for various manufactured products.
• The position requires me to maintain numerous Excel sheet that needs to be updated as documents get updated and or uploaded into their EDMS system.
• The position requires good GDP and GXP on an ongoing basis. Thermo Fisher Scientific, San Diego, CA
Quality Document Specialist/ Labelling Specialist
Apr 2022 - Nov 2022
• Created Excel sheets to track documents to be uploaded and review documents with issues.
• Created various Excel spreadsheets and checklists to track the changes at all stages of the process and ECO tracking updates.
• Created Excel spreadsheets to aid document tracking and SAP uploading Status.
• Created the ECO Change Request for these label changes, processing the documents labels and uploading all the documentation needed for these changes into their Agile data management PLM system.
• Trained in the Agile Documentation System at DJO Global.
• Create and modify labelling for product labels and dealt with labelling issues for products.
• Updating labels with required Hazard symbols and information. Beckton& Dickenson/BO Biosciences, San Diego, CA
Quality Document Specialist/ Labelling Assistant
Apr 2020 - Jan 2022
• Maintained various company logs such as their Master Parts Item log. CO logs, Quality documents log, using spreadsheets in Excel and updated parts and information in their Made to Manage Software.
• Was responsible for filing all hard copies and in charge of obsoleting documents and maintaining the logs related to this process.
• Responsible for printing and proofing 9,000 labels for an urgent project with a targeted end-of-the-year completion.
• The labels were printed using ZM400 and Z4Mplus printers.
• The label was put on PDFs which had to have their text converted using Java Script after they had been proofed, scanned, and uploaded into SAP.
• The SAP file related to the labels had to be updated, was required to create Excel spreadsheets for each label batch listing the individual labels which were selected at random and reviewed within the printed batches.
• Responsible for notifying my team when the process was completed.
• Used SAP EDMS software, Microsoft Office, Adobe Acrobat Reader and DC Pro, Microsoft Teams, Word, and various printers.
• Had TSA training and various online required training for the position. Illumina, San Diego, CA
Document Specialist II
Nov 2019 - Mar 2020
• Reviewing, uploading, and archiving of all Illumina construction architectural drawings for the Facilities group.
• These drawings included As-builts, Electrical, Mechanical, Plumbing, Design Development, Plan Check, Permit Sets, Submittals and Bid Sets for all their California and Wisconsin building locations from 2000 to the present.
• Used Meridian EDMS software, SAP, and Auto Cad 17. Beckton & Dickenson, San Diego, CA
Quality Specialist
Jan 2019 - Apr 2019
• Review Documents, SOP, SWI and the labelling when inspecting
• Perform Quality inspections of products, help to resolve a CAPA issue, and help to maintain training modules
• Maintain calibration of equipment onsite and out-of-tolerance issues.
• Maintained various company logs such as their Master Parts Item log. CO logs, Quality documents log, using spreadsheets in Excel and updated parts and information in their Made to Manage Software.
• Was responsible for filing all hard copies and in charge of obsoleting documents and maintaining the logs related to this process.
• Responsible for printing and proofing 9,000 labels for an urgent project with a targeted end-of-the-year completion.
• The labels were printed using ZM400 and Z4Mplus printers.
• The label was put on PDFs which had to have their text converted using Java Script after they had been proofed, scanned, and uploaded into SAP.
• The SAP file related to the labels had to be updated, was required to create Excel spreadsheets for each label batch listing the individual labels which were selected at random and reviewed within the printed batches.
• Responsible for notifying my team when the process was completed.
• Used SAP EDMS software, Microsoft Office, Adobe Acrobat Reader and DC Pro, Microsoft Teams, Word, and various printers.
Hologic, San Diego, CA
Quality Document Specialist, Labelling Design Department Apr 2017 - Dec 2018
• Working as a Document Specialist working with the Design Labelling group and the Regulatory group, was responsible for reviewing and updating Hologic product Labels using Adobe Illustrator on Apple Mac and Photo Shop Software.
• Was responsible for reviewing the change of Address and other information on various labels.
• Created the ECO Change Request for these label changes, processing the documents labels and uploading all the documentation needed for these changes into their Agile data management PLM system.
• Created various Excel spreadsheets and checklists to track the changes at all stages of the process and ECO tracking updates.
• Maintained this information using Share point, Oracle, Outlook, and OneNote Software. Zest Dental Solutions, Escondido, CA
Quality Document Specialist II
Feb 2015 - Feb 2017
• Working as Document Specialist, was responsible for Creating, reviewing, and updating customer Labels using Bartender Software.
• Processing ECO Change Request, Processing Engineering Validation\Verification documents, Test Protocols and Reports.
• Maintained Deviation documents, Non-Conforming Material documents, Company employee Training records, and Risk Management documents and created or revised BOM's in their ERP systems.
• Maintained various company logs such as their Master Parts Item log. CO logs, Quality documents log, using spreadsheets in Excel and updated parts and information in their Made to Manage Software.
• Responsible for filing all hard copies and in charge of obsoleting documents and maintaining the logs related to this process.
CareFusion, San Diego, CA
Quality Assurance Assistant
Sep 2014 - Nov 2014
• Working as an outside auditor for the SOX Risk group reviewing, verifying IT configuration workflow within SAP, and maintaining their Monitoring firefighter logs.
• Escalating overdue workflow, Uploading Bad documents into SAP, Monitoring IT Security inputs.
• Updating related spreadsheets in excel.
• Reviewing Business documents (BAD) for completion and forwarding to approvers using SAP DMS.
• Maintaining documentation in preparation for future FDA Sox audits. DJO Global, San Diego, CA
Document Specialist
Dec 2013 - Jul 2014
• Working in DJO's PDM department, responsible for auditing Word Documents, Solid Works, Auto Cad Drawings revving documents in their Oracle database and Data Mining.
• Reviewed PDFs and Solid work drawing for the correct revision that were migrated and uploaded into their new Agile Documentation System, searched, and gather CO/ECO documentation for product changes.
• Created Excel sheets to track documents to be uploaded and review documents with issues.
• Trained in the Agile Documentation System at DJO Global. CareFusion, San Diego, CA
Senior Quality Document Control Analyst
Aug 2011 - Dec 2011
• Responsible for uploading all documentation for CareFusion IT Risk Management Department and QA Validation Department.
• Lead document incorporator and coordinator responsible for uploading all test scripts, Design Review Business documentation (BAD), Validation documents, Configuration Procedures, product Life Cycle documents, Test scripts, TDs, and FDs into the SAP Document Management System according to ISO 13465.
• Did SAP training which involved technical writing on some sops and SWls for my group.
• Utilize Excel to create various spreadsheets to keep track of documents, routing destination and the SAP status.
• Utilized Share Point to organize documents for their Audit Remediation project in preparation for possible future FDA and SOX audits.
Clean Airpower, Poway, CA
Document Control Specialist
Jul 2011 -Aug 2011
• Responsible for creating BOM's for their Volvo truck engine adapter.
• Utilize ROI storage Software for the document management system.
• Checked BOM's for accuracy, correct information, and correct revisions. CareFusion, San Diego, CA
Senior Quality Document Control
Apr 2007 - Apr 2011
• Responsible for all the documentation on two major projects.
• Utilize SAP, uploading all project documents into SAP.
• Checked documentation for accuracy, appropriate signatures, correct template usage, and history layout for eventual FDA Audit.
• Created Excel spreadsheets to aid document tracking and SAP uploading Status.
• Trained personnel in SAP procedures and handled all related problems with the documentation on the projects.
• Wrote some SOPs for SAP document uploading.
• Sorting and storing medical design history files, Design Review Documents, Drawings, and related documents using the SAP database.
• Did GDP, wrote some SOP and did training in SAP procedures.
• Created file names and numbers allowing documents to be retrieved and tracked.
Contact this candidate