Document Control Specialist - Rocklin, United States - MilliporeSigma

    MilliporeSigma
    MilliporeSigma Rocklin, United States

    2 weeks ago

    Default job background
    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.

    Translation Reviewer: Responsible for managing translation projects within the Document Control department.

    Responsibilities


    • Identifying the need for translations in 22 languages for IVDR projects


    • Generating necessary reports


    • Assist with coordinating with translation supplier and defining deadlines


    • Reviewing translations and translated templates using online translation tools, translation glossary and AI


    • Populating IFUs, SSPs, DoCs and other document templates with translated segments


    • Implementing corrections to IFUs in various languages as necessary


    • Assis with coordinating corrections with the translation supplier


    • Uploading and verifying glossary entries


    • Verifying IFUs generate in various languages without errors and troubleshooting errors that may occur.


    • Assist with reporting translation costs, turnarounds and expected project completion


    • Maintaining translation files and records

    Qualifications:


    • Experience with translations desired


    • Excellent communication skills


    • Project management abilities


    • Excellent attention to details