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.