Document Control Specialist

3 weeks ago


Rocklin, United States ProKatchers LLC Full time

Job Title: Document Control Specialist

Location: 95677, Rocklin, California, United States

Duration: 12 Months


Job 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.
  • 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.
  • Work with Originators in following up, analysing, and helping to resolve open change control issues.
  • Process product labelling and instructions for use labelling for creation and updates. Implement labels per quality procedures.
  • May be required to perform additional administrative duties to support Quality organization i.e., filing, organizing, and cataloguing records.
  • 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.
  • Responsible for managing translation projects within the Document Control department.


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