Quality Assurance Analyst
2 weeks ago
True Title: Translation Reviewer
1 Year
Rocklin, CA
PR: $28 - $30.00/hr
Summary
- 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
- 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.
Qualifications
- Experience with translations desired
- Excellent communication skills
- Project management abilities
- Excellent attention to details
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