Quality Control Management

John Lee

* ******* **. ******, ** *****

Cell: 201-***-****

****.*.****@*****.***

OBJECTIVE

To apply for Regulatory Document Specialist position where I can utilize my expertise in regulatory documentation in order to meet the company’s business objective

QUALIFICATIONS

Regulatory eCTD Publishing

Experience with IND, NDA, NeeS

Ability to review and format scientific or regulatory documents into submission-ready

Microsoft Word, Mic. Excel, Adobe Acrobat, ISI Toolbox, eCTD Express

Electronic Document Management System

Demonstrated ability to review and format government documents for logistics department

Bookmark and hyperlinking documents

Authoring templates, formatting and publishing documents to follow regulated guidelines

Knowledge of requirements and guidelines for both paper and electronic documentation

Able to multi-task and prioritize, well organized, detail oriented, works effectively under pressure

Able to provide leadership on cross-functional team and work effectively in a matrix environment

Understanding of Windows operating systems including Windows server (Microsoft Certified Professional), Apple

operating system, and UNIX operating systems

Fluent in Korean

EDUCATION

Rutgers University, New Brunswick, NJ

B.S. Environmental Business and Economics 2006

Cittone Institute, Paramus, NJ

Network Systems Professional 2003

WORK EXPERIENCE

Joy Systems, Somerset, NJ – March 2013 – Current

Senior Technician, Quality Control

Designed and fabricated computer systems according to both company and customer specifications. Developed and installed computer system images. Maintained quality control on all company products ensuring all products are compliant to company standards.

Responsible for creation, assembly, and publishing of audit reports for all returned computers. Audit reports include computers from both vendors and individual customers. Reports adhere to company requirements and guidelines.

Troubleshoot computer systems and implementing corrections according to company guidelines. Debugged various computer system images for multiple systems to ensure quality control.

Contributed in writing SOPs/Work instructions to ensure efficiency and consistency across all departments

Image Solutions, Inc., Whippany, NJ – March 2012 – March 2013

Regulatory Documentation Specialist

Published drug submissions using Adobe Acrobat, ISI Toolbox, and publishing tool

Bookmarked, hyperlinked, scanned documents

Led the team in projects that involved coordinating resources, publishing and verifying the submission

Communicated with client to bring up issues and resolve, project status report, and ensure timeline is met

Lee and Min Corporation, Multiple locations – February 2005 – March 2012

Operations Director

Helped maintain day to day operations of several stores coordinating all activities, driving daily business, training employees, maintaining inventory management, and assess risk management

Manage daily operations by meeting customer timelines and deliverables according to customer needs.

Managed daily business through advertising and promotion

Tracked product complaints, coordinate complaint returns, act as a liaison between complainant and service division

Kept accurate business model, status reports and general ledger of several stores

Gained teamwork and leadership skills

Department of Defense, Multiple locations – June 1999 – February 2005

Head of Administration and Logistics - United States Marine Corp Reserve Duty – June 1999 – February 2003, February 2004 – February 2005

Created and maintained accurate accountability of all company personnel (over 120 marines) and equipment (over 1000 pieces) while on Reserve Duty

Provided quality control and assurance review for administrative documents, both paper and electronic

Developed knowledge and experience in day to day operations ensuring data accuracy on all paper and electronic documents for company logistics

Communicated effectively with team members from the various departments in order to assure data accuracy for all paper and electronic documents

Demonstrated proficiency with multiple PC software applications including MS Word, MS Excel and Adobe Acrobat, applied this expertise to job responsibilities

Head of Administration and Logistics - United States Marine Corp Active Duty – February 2003 – February 2004

Created personnel rosters (over 850 marines) and equipment rosters (over 4000 pieces) for entire battalion (6th Motor Transport Battalion) before and during Operation Enduring Freedom in Iraq and Kuwait

Created personnel rosters (over 70 marines) and equipment rosters (over 1000 pieces) for Headquarters and Service company (within 6th Motor Transport Battalion) during Operation Iraqi Freedom in Iraq and Kuwait

Communicated with management to bring up issues and resolve, project status report, and ensure timeline is met

Archived logistical documentation into electronic database ensuring storage, accessibility, and maintenance

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