MARGARET-MARIE O. MILES

Colorado Springs, Colorado 80920 970-***-**** ac5z1f@r.postjobfree.com

Quality-focused Manufacturing Engineering Professional; offering excellent technical writing abilities and Strong computer skills. Able to identify continues improvements in manufacturing operations within a six-sigma lean manufacturing environment. Capable of utilizing corrective & preventative actions (CAPA), and Quality System Regulations methods gained through the Colorado State University's Regulatory Affairs -Medical Device Certificate Program. Familiar with compliance related activities such as validation and verification processes. persistent, methodical approach to all undertakings and assignments. Knowledge of cGMP regulations to include 21 CFR 820 and ISO 13485. Delivered this and more for over seven years with expertise in the following:

Quality Control/Assurance Clean Room Environment Statistical Process Controls

Tensile Testing Continuous Process Improvement Vendor Cost-Benefit Analysis

Scientific Instrumentation Staff Training and Leadership Research Design/Implementation ACADEMIC CREDENTIALS

Colorado State University, Fort Collins, Colorado

Professional Certificate in Regulatory Affairs, Medical Device, IVD, & Tissue Industry (May 2014) Relevant Coursework: Regulatory Affairs for Pharmaceutical and Biologics Industry; Quality System Regulations and ISO 13485 Regulations; Good Laboratory Practices; Design Controls for the Medical Device Industry Wayne State University, Detroit, Michigan

Candidate for Master of Science (M.S.): Biomedical Engineering (Attended 2009) Relevant Coursework: Introduction to Molecular Biology for Engineers; Introduction to Cell Biology and Physiology for Engineers; Engineering Physiology; Seminar in Biomedical Engineering Wayne State University, College of Chemical Engineering and Material Science, Detroit, Michigan Bachelor of Science (B.S.): Chemical Engineering, Concentration in Biological Engineering (May 2007) TECHNICAL SUPPORT EXPERIENCE

Tek Experts Inc.: Microsoft Support Division Contract- Colorado Springs, Colorado 2016 -Present Technical Support Advisor

Summary: The management point of contact for Microsoft’s critical situation cases at a severity level A. Providing management support for a minimum of 7-8 cases in multiple regions across the United States along with support in countries such as Netherlands, Switzerland, Germany, India, United Kingdom and other English-speaking countries overseas.

Provided team leadership support for the Tek Expert Management Team which involved troubleshooting outlier cases and managed the queue by distributing caseloads to technical support advisors.

Trained approximately 20 new Technical Support Advisors to managed 4-5 incident management cases for fortune 500 clients of Microsoft.

Internally reviewed approximately 30 executive level compositions per day before the technical summaries were viewed by VIP's and stakeholders.

Approved by Microsoft Corporation to provided technical writing and interpret engineering notes from Microsoft Mssolve tool for companies across various regions.

Wireless Technical Support Web-Chat – Xerox Corporation, Highland Ranch, Colorado 2015-2016 Technical Support Advisor

Summary: Provides level 2 technical support across the United States, for Verizon Wireless customers. Assist end users over a supported online web application utilizing co-browse applications to provide Wireless accounts and device support. Troubleshoots network outages, device activation, iCloud Support, Verizon Cloud Wireless backup support, Global international Travel and customer billing.

Primary Deliverables and Accomplishments:

Responded to client account questions, including billing and plan change request

Utilized remote sessions across end user's mobile device, tablets and Desktop workstations to resolve cloud application, and software application issues.

Researched diagnostics support tools to provide quick solutions for end users. PROFESSIONAL RESEARCH EXPERIENCE

University of Michigan: Department of Emergency Medicine- Ann Arbor, Michigan 2007 - 2011 Life Science Research and Procurement/ Laboratory Management Summary: Led a 6-person scientific research team, under the direction of Dr. John Younger; in the development of “large multicellular structures with Klebsielle Pneumoniae under bloodstream-mimicking fluid dynamic conditions”. This project, funded by the Public Health Department, expanded in collaboration with the University of Colorado at Boulder’s Applied Mathematics Department and the University of Michigan’s Chemical Engineering Micromolecular Science and Engineering group. Primary Deliverables and Accomplishments:

Partnered with Dr. John Younger, Solomon Professor of Chemical Engineering at the University of Michigan, and Dr. David Bortz, Mathematics Professor at the University of Colorado in the execution of this clinical research project. Results were published in the Journal of Infectious Diseases and were also accepted into the American Journal of Respiratory Cell and Molecular Biology.

Performed all associated experiments to include culturing pure microbes in a flask and developing medial for the microbes; the latter of which entailed formulating media from scientific literature, developing growth kinetic curves for the bacteria, creating statistical data, and isolating RNA. Routinely presented findings to the research team.

Supervised experiments performed by both graduate and undergraduate students; facilitating training for up to 3 members at a time on microbiology concepts and methods such as growth of pure bacterial strains, flow cytometry, and PCR methods for RNA measurements.

Developed project schedules and SOPs for experiments, equipment maintenance, installation and calibration of equipment, process improvement, and aseptic/clean room methods; all which resulted in accurate, quality-driven, and on-time projects.

Maintained budgetary alignment by managing to laboratory costs, negotiating with external vendors, and innovating procurement processes.

Expertly managed and coordinated all incoming and outgoing shipments for domestic/international materials supplies valued at over $5K, resulting in 98% on-time deliveries and projects.

Saved $30K for the department by choosing not to purchase a zeta potential device; instead networking with the University’s Pathology department to assist in the measurement of multicellular particles. Wayne State University: Department of Chemical Engineering- Detroit, Michigan 2006 - 2007 Stem Cell and Tissue Engineering Research

Summary: Requested and selected to independently manage a stem cell research project as an undergraduate student. Over the course of one year; was able to formulate three dimensional polymeric scaffolds utilizing a novel freeze-drying aseptic method which resulted in successfully producing controlled pore sizes for the tissue scaffolds. Primary Deliverables and Accomplishments:

Planned and coordinated entire research project from concept to completion. Utilized scientific journals to develop methods for protocols; created spreadsheets for collection of data; measured viability of cells; cultured cells/tissues; formulated media; analyzed stem cell differentiation; and managed project timelines.

Executed quality-driven clean room procedures to create biologically-active polysaccharide scaffolds; successfully carrying out the project contaminate free for 14 days; allowing for replicable research results.

Prepared the seeding of stem cells on 3-D scaffolds and differentiated adult stem cells with TGF-beta-1 growth factor resulting in a pure cell-line of chondrocyte utilizing aseptic techniques.

Prepared and organized the isolation method for retrieving rat bone marrow utilizing aseptic/clean room techniques which resulted in in harvesting a pure cell-line of an adult stem cell. Additionally assisted graduate students with Biomarker assays on bone regeneration novel methods.

Recognized by Academic leadership at the Creative Project Conference; competing against 260 undergraduate participants yet still selected twice to present project abstract. Additionally invited to present at following years conference.

Researched and authored a nationally-recognized publication on biologically-active polysaccharide materials and adult stem cells. Received a travel award to formally present research findings at the NOBBCHE National Conference. PROFESSIONAL WORK EXPERIENCE

Contracted through Butler Services and recruited by Exxon Mobil Corporation in Romulus, Michigan to serve in an Engineering Manufacturing and Equipment Management role for one of only two pilot management programs executed between General Motors

(GM) and Exxon Mobil Corporation. As their key lead Lubrication Technician, was tasked in expanding the sale of Exxon Mobil products in the plant. Earned position prior to attending college; sparking an intense interest in the manufacturing engineering field and subsequent studies.

Primary Deliverables and Accomplishments:

Represented Mobil Oil at the GM plant in Romulus; implementing and managing the pilot Mobil Oil product program while offering cost-effective options for GM’s substantial lubrication product needs.

Designed an innovative mapping system for monitoring lubrication mechanical systems that could be incorporated into GM’s P&ID engineering programs. Efforts resulted in a 35% increase in plant awareness for controlling oil leaks on assembly lines.

Documented and verified viscosity for all oil products entering the plant; analyzing performance trends on gear systems and checking for potential problems and/or defects. Interventions resulted in a 15% decrease in part replacements.

Advised GM’s Maintenance Engineering Department on quality concerns related to the current status of the oil conditions on assembly lines, resulting in 10-15% decrease in equipment downtime.

Remotely partnered with GM Engineers from Italy and Maintenance Engineers on-site to review P&ID engineering documents. Advised management teams on the correct oil type for the new assembly lines; analyzed oil conditions; developed trend analysis reports within the six-sigma lean manufacturing environment; procured products; and formally reported findings to site engineering teams and senior leadership.

EMPLOYMENT HISTORY

Critical Situation Manager: Tek Experts Inc. For a Microsoft contract, Colorado Springs, Colorado 2016 - Present Wireless Technical Support Web-Chat: Xerox Corporation, Highland Ranch, Colorado 2015 - 2016 Help Desk Advisor (Contract)- Forest Service Department of Agriculture, Boulder, Colorado 2013 – 2015 PROFESSIONAL SCIENTIFIC PUBLICATIONS

Thornton, M. and Dr. J. Younger. “Multicellularity and Antibiotic Resistance in Klebsiella Pneumoniae Grown under Bloodstream- Mimicking Fluid Dynamic Conditions.” The Journal of Infectious Diseases, February 2012. Thornton, M. “In Vitro Cartilage Generation using Mesenchymal Stem Cells in 3D GAG-Chitosan Scaffolds.” NOBBCHE National Conference Journal, April 2007.

OTHER RELEVANT INFORMATION

Technical Proficiency: Windows and Mac OSX Operating Systems and all associated software (MS Word, Excel, PowerPoint and Outlook). Scientific platforms and software to include MathCAD Professional; Mathlab; Endnotes v10; Minitab; Image J; SPSS 19; Sigma Plot 11; and HYSYS Aspen. Tensile testing, ERP Systems to include M-Marketsite.

Example Laboratory Instrumentation: Flow Cytometer; RNA Machine; SEM and other Microscopes; Electrophoresis; Nano Drop 2000; RT-PCR; Applied Bio-System; Spectrophotometer; Autoclave Unit; Centrifuge.

U.S. Security Clearance: Details available upon request. Strong professional references available. For more information, please view my LinkedIn profile.

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