Document Control Specialist

3 weeks ago

Rocklin, United States MilliporeSigma Full time

• 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

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