Create and revise technical manuals using various Adobe and CAD software.Generate installation and operation guides with same software.Develop machine-specific instruction sheets for employees and customers.Maintain machine-specific literature on company's website.Create and revise data plates for machine electrical requirements.See About section and my resume for more.

• Ensured customer satisfaction and specific requirements for assigned programs were met. • Scheduled and made calls on new target accounts.• Supported corporate marketing in the development and implementation of the marketing plan.• Provided input to marketing department for promotional/advertising activity (exhibits, print advertising, etc.).• Communicated with all elements of business unit to ensure customer satisfaction.• Monitored progress of bids through the business… Show more • Ensured customer satisfaction and specific requirements for assigned programs were met. • Scheduled and made calls on new target accounts.• Supported corporate marketing in the development and implementation of the marketing plan.• Provided input to marketing department for promotional/advertising activity (exhibits, print advertising, etc.).• Communicated with all elements of business unit to ensure customer satisfaction.• Monitored progress of bids through the business unit’s system.• Generated and maintained customer and competitor profiles and issued periodic updates to team members.• Received and evaluated all program reports and initiated appropriate actions.• Prepared status reports on assigned programs for team members and customers.• Provided finance and marketing with monthly new business forecasts and target accounts activity.• Prepared forecast for total annual sales of assigned products/customers.• Coordinated and tracked internal projects including responsible personnel, timelines, status, and budgets. Show less

• Kept secondary-operation equipment functioning properly, including vibration/ultra-sonic welders and pad-printers.• Verified correct programs were in place and modified when necessary.• Coordinated pad-printing operations including ink-analysis and proper equipment (clichés, pads, etc.).• Worked with experts in both fields to troubleshoot issues.• Coordinated installation of secondary-operation equipment as new business arrived.• Designed new systems and processes for the… Show more • Kept secondary-operation equipment functioning properly, including vibration/ultra-sonic welders and pad-printers.• Verified correct programs were in place and modified when necessary.• Coordinated pad-printing operations including ink-analysis and proper equipment (clichés, pads, etc.).• Worked with experts in both fields to troubleshoot issues.• Coordinated installation of secondary-operation equipment as new business arrived.• Designed new systems and processes for the introduction of new products or the improvement of existing products.• Evaluated manufacturing processes by compiling data and soliciting observations from operators.• Developed manufacturing processes by studying product requirements; researching, designing, modifying, and testing manufacturing methods and equipment; conferring with equipment vendors.• Improved efficiency of processes by analyzing and planning work flow, space requirements, and equipment layout.• Prepared product and process reports by collecting, analyzing, and summarizing information and trends.• Served as on-site IT.• Oversaw the production-reporting system, including troubleshooting issues and installing new equipment.• Maintained all site servers, including server back-ups.• Deployed, connected, and maintained information-display screens.• Maintained phone systems.• Troubleshot daily user issues.• Maintained camera systems.• Responsible for new equipment installation (PCs, printers, teleconference equipment, etc.). Show less

• Oversaw the Quality Management System (MQ1).• Maintained the electronic Document Management System.• Created/revised/edited documents which supported the Quality System.• Monitored documentation to ensure usability and understanding at all levels.• Ensured document compliance with ISO 9001/TS 16949.• Managed the Change Control System.• Conducted audits of the system.• Ensured on-time document approval.• Distributed Quality Alerts to affected… Show more • Oversaw the Quality Management System (MQ1).• Maintained the electronic Document Management System.• Created/revised/edited documents which supported the Quality System.• Monitored documentation to ensure usability and understanding at all levels.• Ensured document compliance with ISO 9001/TS 16949.• Managed the Change Control System.• Conducted audits of the system.• Ensured on-time document approval.• Distributed Quality Alerts to affected areas.• Monitored the status of projects to ensure documentation was submitted according to schedule and complied with established guidelines.•Maintained the electronic Inventory Management System (Macola ES).• Entered new items into the system.• Monitored item location quantities and status.• Created a Bill of Material (BOM) for each finished good.• Created routings for each finished good and work-in-process (WIP).• Confirmed that the process flow for product was accurately represented in the BOM.• Ensured inventory was relieved properly.• Ensured proper labor rates and designations were in the system.•Oversaw Regulatory Compliance.• Managed submissions to the International Material Data System (IMDS).• Created new submissions to the IMDS. • Ensured submissions met client timelines.• Managed reporting on Conflict Minerals.• Researched sourcing of materials to provide for accurate reporting.• Reported to customers using the iPoint Conflict Minerals Platform (IPCMP) and/or the Electronic Industry Citizenship Coalition and Global e-Sustainability Initiative (EICC – GeSI) Conflict Minerals Reporting Template.• Wrote and maintained declarations of compliance concerning Conflict Minerals.• Managed reporting on NAFTA source of origin.• Researched and applied appropriate tariff classifications for U.S., Canada, and Mexico.• Completed and submitted accurate CBP Form 434 and Manufacturer’s Affidavit to importers. Show less

• Managed the Document Control Department.• Supervised Document Control Personnel.• Oversaw the electronic Document Management System (MetricStream).• Wrote/prepared/edited regulatory documents for nuclear medicine products, including:• Regulatory responses.• Annual Reports.• Managed disaster recovery for critical records, including batch records and validation protocols.• Created and presented Good Manufacturing Practice (GMP) training.• Monitored employee… Show more • Managed the Document Control Department.• Supervised Document Control Personnel.• Oversaw the electronic Document Management System (MetricStream).• Wrote/prepared/edited regulatory documents for nuclear medicine products, including:• Regulatory responses.• Annual Reports.• Managed disaster recovery for critical records, including batch records and validation protocols.• Created and presented Good Manufacturing Practice (GMP) training.• Monitored employee training and ensured timely completion.• Created and managed a periodic review system.• Participated in site-wide committees and charter teams with a goal of streamlining and improving systems and processes.• Ensured team compliance with all policies, procedures, training, and site/company/agency regulations.• Ensured site compliance with Food and Drug Administration (FDA), National Regulatory Commission (NRC), and European Union (EU) regulations concerning documents/records.• Held weekly team meetings to update employees and tracked progress through established metrics.• Managed the department’s overtime, within budget and need, and ensured that all exception reports are completed and submitted on time to Payroll bi-weekly.• Led team in continuous improvement activities. Show less

Manage CLI's Document Systems Department.Provide eCTD support to clients.Manage the CLI portal, which is used to share documents with clients.Research FDA, EU, and ICH regulations.Ensure document compliance with FDA, EU, and ICH regulations.Assist in regulatory and client audits.Manage CLI's Standard Operating Procedures (SOPs).Issue all SOP numbers and maintain SOP logbook.Edit all SOPs before they become effective.Write critical SOPs requiring Quality… Show more Manage CLI's Document Systems Department.Provide eCTD support to clients.Manage the CLI portal, which is used to share documents with clients.Research FDA, EU, and ICH regulations.Ensure document compliance with FDA, EU, and ICH regulations.Assist in regulatory and client audits.Manage CLI's Standard Operating Procedures (SOPs).Issue all SOP numbers and maintain SOP logbook.Edit all SOPs before they become effective.Write critical SOPs requiring Quality Assurance and client approval.Reformat and revise SOPs for all departments.Stamp SOPs effective and upload to the electronic system.Manage CLI's Material Specifications (MSs).Issue all MS numbers and maintain MS logbook.Edit all MSs before they become effective.Create MSs in consultation with subject-matter experts.Communicate with clients, suppliers, and manufacturers.Process all client-specific documents.Stamp MSs effective and upload to the electronic system.Work daily with the Microsoft Office Suite.WordStylesTables/ figuresHeaders/footersConvert to .pdfImport Excel fileImagesTemplatesMail mergeContent controls Document protectionComments/track changesGraphicsExcelFlat data tablesData filtersPivot tablesFile trimmingName fields/rangesCharts/graphsForm controlsFormulasPowerPoint, Outlook, Publisher.Work daily with Adobe Acrobat Professional.Create electronic forms for various departments.Ensure document security.Oversee digital signatures.Ensure FDA compliance.Manage electronic document systems.Review and approve calibration records.Issue Test Method (TM) numbers and maintain TM logbook.Work under deadlines, including FDA audits.Audit client-specific documents in preparation for FDA audits.Help prepare Document Systems for FDA audits by:Auditing department SOP binders.Writing needed SOPs.Revising.Editing and revising the company's SOP index.Editing and revising the company's MS index. Show less

Write Standard Operating Procedures (SOPs).Issue all SOP numbers and maintain SOP logbook.Edit all SOPs before they become effective.Write critical SOPs requiring Quality Assurance and client approval.Reformat and revise SOPs for all departments.Stamp SOPs effective and upload to the electronic system.Create Material Specifications (MSs).Issue all MS numbers and maintain MS logbook.Edit all MSs before they become effective.Create MSs in consultation with… Show more Write Standard Operating Procedures (SOPs).Issue all SOP numbers and maintain SOP logbook.Edit all SOPs before they become effective.Write critical SOPs requiring Quality Assurance and client approval.Reformat and revise SOPs for all departments.Stamp SOPs effective and upload to the electronic system.Create Material Specifications (MSs).Issue all MS numbers and maintain MS logbook.Edit all MSs before they become effective.Create MSs in consultation with subject-matter experts.Communicate with clients, suppliers, and manufacturers.Process all client-specific documents.Stamp MSs effective and upload to the electronic system.Work daily with the Microsoft Office Suite.WordStylesTables/ figuresHeaders/footersConvert to .pdfImport Excel fileImagesTemplatesMail mergeContent controls Document protectionComments/track changesGraphicsExcelFlat data tablesData filtersPivot tablesFile trimmingName fields/rangesCharts/graphsForm controlsFormulasPowerPoint, Outlook, Publisher.Work daily with Adobe Acrobat Professional.Create electronic forms for various departmentsEnsure document security.Work under deadlines, including FDA audits.Audit client-specific documents in preparation for FDA audits. Show less

Edited material the company was considering for publication. Edited material before print.Designed and maintained event website with Adobe Dreamweaver CS3—www.sallygapbgfestival.com—including photographs, graphics, and content writing.Wrote letters to bands, fans, sponsors, and the media.Wrote memos and reports.Wrote proposals to potential sponsors—local, regional, national, and international.Designed and updated advertisements, signs, brochures, and business cards as… Show more Edited material the company was considering for publication. Edited material before print.Designed and maintained event website with Adobe Dreamweaver CS3—www.sallygapbgfestival.com—including photographs, graphics, and content writing.Wrote letters to bands, fans, sponsors, and the media.Wrote memos and reports.Wrote proposals to potential sponsors—local, regional, national, and international.Designed and updated advertisements, signs, brochures, and business cards as necessary. Worked with Adobe Photoshop CS3, including:• Compositing• Layers• Vector drawing• Paths• Layer masks • Internet vs. print resolution• Image processing• RGB vs. CMYK• Vector vs. raster • FiltersWorked with Adobe InDesign CS3, including:• Layers• Frames• Text wraps• Layer masks • Newsletters• Printing• Brochures • Paragraph styles Show less