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Yyyyyy x. yyyyyy

0000 xxxxxx xxxx , xxxx , xxxxx 00000 xxx-xxx-xxxx


Experienced quality management and information technology professional with 20+ years of experience in high-stress environments along with a strong background within a variety of industries. Experienced in overseeing all quality processes, implementing technical business systems, maintaining business applications, supervising cross-functional teams, and managing large-scale technical projects. Equipped with a significant level of communication and interpersonal abilities in addition to a strong knowledge of event/CAPA management, document management, change control, quality systems, and supply chain management


Key Competencies


         Business System Development

         Team Leadership/Management

         Regulatory Compliance

         Strategy Development


         Technical Project Management

         Document Management

         Change Control

         CAPA Management


         System Validation/Testing

         Complex Problem Solving

         System Networking

         eGMP/FDA Compliance


Technical Skills


Proficient in: Trackwise, Documentum, ETQ, SAP Integration, ComplianceWire, Windows NT 4.0 Track, Windows NT Server 4.0, Windows NT Workstation 4.0, Windows NT Enterprise, TCP/IP Networking, Citrix Metaframe Environment, Oracle Database, Unix, PL/SQL, Win-Runner, Lead-Runner, Test Director, HP Quality Center, HP ALM, Crystal Reports, Macros, Microsoft Office Suite, and Microsoft Visio


Professional Experience

Johnson & Johnson July 2007-Present

Lead-Quality Systems Design Management (2010-Present)

  • Directly manage technical and logistical functions which includes monitoring various internal business systems which are responsible for documental control, compliance, and validation
  • Create detailed system processes/controls which ensure that business processes are completed accurately, monitor internal compliance with FDA regulations, and update SOP s as needed
  • Utilize exceptional communication abilities in order to foster positive collaboration with internal users in addition to identifying expected service level requirements
  • Maintain the EDM, RCTS, and Einfotree systems, analyze current business process in order to ensure compliance with quality/regulatory requirements, and provide training to users
  • Played an integral role in the integration of EDM to compliance wire which resulted in streamlining internal training processes and improving efficiency
  • Lead the completion of in-depth document/management system related investigations which includes completing root cause analysis, identifying the impact of system issues, and creating resolutions
  • Manage both the Quality Systems Improvement Plan and Event Management/CAPA Assessment Programs which included reviewing business processes and making improvement recommendations
  • Acted as a member of the Quality System Improvement Plan team which included overseeing an internal document management tools, assessing current systems, and developing recommendations for improvement
  • Supported a new quality standards and continuous improvement management system by translating business requirements and assisting in selecting the appropriate automation tools


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Yyyyyy x. yyyyyy

0000 xxxxxx xxxx , xxxx , xxxxx 00000 xxx-xxx-xxxx


Professional Experience Continued:

Sr. Analyst, Quality Information Systems Technical Lead (2008-2010)

  • Guided the day to day management of the internal TrackWise system which required developing appropriate software applications, maintaining current processes, and overseeing data integration processes
  • Oversaw the management of various system events such as deviations, investigations, CAPA, audit management, commitment tracking, and change control processes
  • Facilitated the standardization of quality system processes with a focus on maintaining alignment with internal best practices, supervised a cross-functional technical team during the build of a ETS-Trackwise Global system, and managed the integration of the ETS-Trackwise system into existing quality systems


Consultant (2007-2008)

  • Assisted users with an event management system which included analyzing software requirements, determining business needs, and documenting the availability of process automation
  • Maintained a keen knowledge of the software development lifecycle which resulted in consistently meeting project deliverables and successfully planning a new system rollout
  • Performed system testing in order to ensure functionality, monitored compliance, performed disaster recovery testing, and managed the change control board for the system


Schering Plough June 2003-June 2007

Global Quality Information System Support: Sr. Quality Analyst

  • Directed several technical and system support functions within a fast-paced environment with a focus on increasing system productivity and overall efficiency within the entire organization
  • Member of the Consent Decree Commitment Team which was responsible for overseeing the deployment of a portal throughout 14 manufacturing sites
  • Played a lead role in the implementation of a reference standards management system used by the global quality group which included a web-based inventory enterprise manager and document manager
  • Assisted in the implementation of a web-based stock keepers system, a complaints management, deviation, and CAPA management system, and an environmental monitoring LIMS system


Additional Professional Experience Includes: Information Management Analyst, Industrial Bearing Corporation


Education & Certifications

Master s of Business Administration, Technology Management

Philadelphia University, Philadelphia, PA (Currently Pursuing)


Bachelor of Science, Computer Science, Magadh University, India


Microsoft Certified Systems Engineer (MCSE # 1543863)


Completed Training Coursework Includes: Fundamentals of Management, The Voice of Leadership: How Leaders Inspire, Influence and Achieve Results, The 7 Habits of Highly Effective People 3 Day Signature Program, Assertiveness Training for Managers, Communication and Interpersonal Skills: A Seminar for Technical Professionals, Building Better Work Relationships: New Techniques for Results Oriented Communication, and How to Communicate with Diplomacy, Tact, and Credibility

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Yyyyyy x. yyyyyy

0000 xxxxxx xxxx , xxxx , xxxxx 00000 xxx-xxx-xxxx







Hiring Agent Name


Company Name


City/State/Zip Code




I am currently seeking a challenging career opportunity in a (INSERT TITLE OF TARGET POSITION) capacity and am submitting my resume for your review. In advance, thank you for your time and consideration.


As demonstrated in the accompanying resume, my professional qualifications include a strong background in quality system management and technical roles within a variety of industries with experience in gathering business requirements, overseeing document control, supervising cross-functional teams, performing system testing, and leading complex system implementations. In addition, I have a keen ability to foster positive rapport with clients, vendors, co-workers, and members of management.


To complement my professional experience, I also possess stellar interpersonal and communication skills with an impressive educational background and an extensive technical skill set.


As an employee, you will find me to be a driven team player committed to supporting you in achieving your objectives through superior performance. I am confident that I could be a valuable asset to your organization, and look forward to interviewing with you in the near future.






Yyyyyy x. yyyyyy


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