DOCUMENT CONTROL SPECIALIST SKILLS, EXPERIENCE, AND JOB REQUIREMENTS

Updated: Mai 29, 2025 - The Document Control Specialist has experience managing document control processes and supporting Product Lifecycle Management Systems. This role requires proficiency in UDI labeling requirements, GS1, GUDID, and overseeing Document Control Change Boards, including preparing agendas and running meetings. The specialist is also skilled in generating training reports, supporting QMS training, and utilizing MS Office and ERP systems, with strong decision-making and troubleshooting abilities.

Essential Hard and Soft Skills for a Standout Document Control Specialist Resume
  • Document Management Systems
  • UDI Labeling
  • GS1 Standards
  • GUDID
  • Product Lifecycle Management
  • ERP Systems
  • Change Control
  • QMS Training
  • Microsoft Office Suite
  • Data Analysis
  • Communication
  • Teamwork
  • Attention to Detail
  • Problem-Solving
  • Time Management
  • Adaptability
  • Decision-Making
  • Organizational Skills
  • Critical Thinking
  • Collaboration

Summary of Document Control Specialist Knowledge and Qualifications on Resume

1. BA in Information Management with 3 years of Experience

  • Related experience working in biology, chemistry, biotechnology, or related science.
  • Related Quality Assurance experience, working in ISO 9001, ISO 13485, and/or GMP environments.
  • Experience as a Document Control Specialist or relevant role.
  • Hands-on experience in the change control management/process and Document Control processes.
  • Experience working in developing SOP, Forms, and Templates
  • Quality auditing experience, ideally in a biotechnology or medical device company.
  • Strong computer skills (MS Office) and working knowledge of Microsoft SharePoint site management and proficiency in MS Office suites, Teams, and Visio.
  • Working knowledge of Agile PLM application or equivalent
  • Proven ability to communicate and present effectively
  • Positive attitude with the ability to work well under stress
  • Hands-on, action-oriented, and demonstrated continual improvement

2. BA in Project Management with 4 years of Experience

  • Document Control working experience
  • Experience with MS Office, Contract Manager (CM) and SharePoint
  • Experience working on various projects including coordinating and executing project issues
  • Experience with engineering, architectural, and construction documents (i.e., maps, drawings, technical specifications, etc.)
  • Strong communication skills and understanding of technical terminology
  • Be familiar with Contract Manager (CM) and SharePoint as the applications used for the project’s document control
  • Experience developing and maintaining the project distribution matrix with support from the Project Administration
  • The ability to maintain a project filing index through the project life cycle
  • Experience monitoring Contract Data Requirements List (CDRL) status and communicate with Contractors timely for any documentation issue
  • Must have strong organizational skills with attention to detail.
  • Effective communication skills, both written and verbal.

3. BA in Management Information Systems with 2 years of Experience

  • Experience working in Document Control or related experience
  • Knowledge of UDI labeling requirements and GS1, GUDID
  • A good working knowledge of Product Lifecycle Management System - implementation and support
  • Experience with Document Control Change Board - preparing an agenda and running the meeting
  • Experience in Training Reports - preparing and distributing status reports on QMS training
  • Experience with Document Control Processes - creating and maintaining an efficient system
  • Must have the ability to read and write English
  • Ability to work and communicate within a team environment
  • Strong user of MS Office (Outlook, Word, Excel, and PowerPoint) and ERP systems
  • Good decision-making and troubleshooting skills

4. BA in Business Administration with 1 year of Experience

  • Working experience in Document Control
  • Advanced SharePoint experience
  • Experience maintaining and reporting for Quality Management Systems (QMS)
  • Proficiency in Microsoft Office suite, with advanced MS Excel skills
  • Detail-oriented with exceptional organizational skills
  • Demonstrated problem-solving ability in a cross-functional environment
  • Innovative, open-minded, collaborative, and a team-oriented attitude
  • Must have a strong work ethic
  • Experience working in the pharmaceutical industry
  • Experience with the Veeva Quality Management System

5. BA in Operations Management with 5 years of Experience

  • Prior medical device or pharma background.
  • Experience contributing to and implementing various process improvements.
  • Related experience with Document Control and Change Management systems
  • Must be proficient with MS Office Suite (e.g. Word, Excel, PowerPoint) and Adobe Acrobat.
  • Knowledge of Quality Management Systems, especially with document control regulatory requirements, preferably in a regulated environment such as the medical devices industry.
  • Experience working with Oracle’s Agile PLM system.
  • Knowledge in the areas of GDP, FDA regulations, and manufacturing processes.
  • Ability to work within a team and as an individual contributor in a fast-paced, demanding, and changing environment.
  • Ability to resolve quality-related issues in a timely and effective manner.
  • Ability to leverage and/or engage others to accomplish projects and goals.
  • Strong analytical skills, problem-solving techniques, and technical aptitude.
  • Ability to effectively communicate at multiple levels in the organization, with strong organizational, and proofreading skills, and attention to detail.
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