Quality Assurance Analyst

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