Documentation Specialist

3 weeks ago


Rocklin, United States Integrated Resources, Inc ( IRI ) Full time

Title: Documentation Specialist

Location: Rocklin, CA

Duration: 12 months+


Description:

  • Participate in projects/assignments that support continuous improvement efforts and department/company goals especially as they relate to translation projects
  • Assist in maintaining quality system documents.
  • Review submitted document change requests to ensure all work and processes comply with established cGMP and other related standards. Provide feedback and request corrections as needed.
  • Process documentation changes in document control system: Ensure electronic capture and retrieval of quality documents and records by reviewing, evaluating and processing changes accurately and in a timely manner while ensuring that they meet the department goals and objectives.
  • Promptly respond to questions and issues raised by Originators and Approvers. Work with Originators in following up, analyzing and helping to resolve open change control issues.
  • Process product labeling and instructions for use labeling for creation and updates. Implement labels per quality procedures.
  • Maintain document control records upon completion, i.e., scanning, filing.
  • May be required to perform additional administrative duties to support Quality organization i.e., filing, organizing, and cataloging records.
  • Support Document Control department activities.
  • Assist in training employees in Document Control processes, specifically translation processes.
  • Follow regulatory and standard requirements as applicable to the site, i.e., MDSAP, ISO 13485, IVDR, and compliance with the site Quality Manual.
  • May be required to perform additional duties as assigned.



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