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Documentation Specialist/Coordinator

Company: Yoh
Location: Rockville
Posted on: November 16, 2021

Job Description:

GSK Rockville Biopharm JOB Description: Documentation Specialist/Coordinator Primary Duties: -An immediate need exists for a Documentation Specialist/Coordinator -to assist the validation and quality groups in receipt and organization of documentation received from vendors and to perform basic technical writing. - Responsibilities include but are not limited to:

  • Organizing backlog of over 1000+ documents (both hardcopy and digital) received from various vendors
  • Receiving, securing, indexing, labeling, and organizing vendor documents for use by the functional groups during the commissioning/qualification activities
  • Assisting -Validation and MQA manager and their designees in tasks associated with project documents
  • Manage document lifecycle for GMP documents per SOP and project VMP
  • Work as assigned by the Validation Lead or to prepare and progress documents through the approval process to meet timelines
  • Organize and secure hardcopy and digital documents Education and Experience Requirements:
    • Associates degree or two years post high school education
    • 2 years of relevant experience
    • Familiarity with commissioning and validation concepts, procedures, protocols and requirements a plus Key Skills, Abilities, and Competencies:
      • Strong communication, organization, and time management skills are necessary
      • Technical Writing and Computer Skills (Word, Excel, etc.) required
      • Ability to develop, organize, and manage multiple tasks
      • A commitment to delivering quality documents and service excellence
      • Must be results-oriented, able to make decisions, and able to prioritize work per business needs
      • Desired skills include: teamwork, ability to maintain constructive relationships with personnel from various disciplines at all levels in the organization Complexity and Problem Solving:
        • The successful candidate should demonstrate integrity, reliability, dedication, adaptability, innovation, and self-motivation Other Job Requirements:
          • The individual must observe all safety requirements (OSHA), GMP regulations (FDA), and housekeeping practices while performing duties #CB-SPG #IND-SPG

Keywords: Yoh, Rockville , Documentation Specialist/Coordinator, Other , Rockville, Maryland

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