Document Controller

4 weeks ago

Concord, United States Medasource Full time

The Document Controller is tasked with executing, maintaining, and administering document management systems. This pivotal role involves aiding in the initial program startup, routine operation, and ensuring site inspection readiness and execution.


Key Objectives/Deliverables:

Responsibilities:

  • Maintain GMP Library document inventory control through the Record Manager (RM) system, as required.
  • Assume the role of Document Controller for all documents and records maintained in the Veeva Quality Docs Electronic Data Management System (EDMS).
  • Ensure training and compliance with global and local Documentation and Records Management requirements.
  • Assist in updating, routing, and approval of electronic documents by appropriate personnel.
  • Manage day-to-day operations and monitor assigned Veeva Vault QualityDocs workflows.
  • Collaborate with internal personnel to review documents and assign Veeva Quality Docs metadata when adding documents into the Veeva Quality Docs EDMS.
  • Manage retention of GMP Related Records in accordance with Document Type and Record Class Codes (RCC), including shipment of GMP records to external storage locations for long-term retention as necessary.
  • Facilitate the reconciliation process for executable records.
  • Support external and internal audits by providing readily accessible records for review by Regulatory Agencies and Notified Bodies, and/or internal auditing and compliance groups.
  • Assist with Site Self Inspections associated with Document Control and the Veeva Vault Q Docs Electronic Data Management System (EDMS).
  • Ensure periodic reviews of documents are performed within Veeva Vault QualityDoc according to company standards.
  • Follow up with document owners to ensure review and updating on a timely basis.
  • Collaborate closely with Quality, Learning and Development, and other functions to ensure their document needs are captured as required.

Basic Qualifications:

  • Education: High School Diploma or equivalent.
  • Experience: Three years of previous document management experience, including working in a regulated environment.

Additional Skills/Preferences:

  • Proficiency in Microsoft Office (Outlook, Word, & Excel).
  • Previous experience in records management, data entry, or similar roles.
  • Demonstrated ability to work successfully in a team environment.
  • Demonstrated Project Management skills.
  • Strong written and verbal communication skills.
  • Strong ability to solve problems and make decisions.
  • Experience with documentation in a GMP environment and electronic tracking of documents.
  • Experience in quality systems such as TrackWise, Veeva Vault QualityDocs.

Additional Information:

  • Ability to work 8-hour days, Monday through Friday, day shift; onsite.
  • Some overtime may be required to support audits as necessary.

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