- 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.
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Document Control Specialist - Rocklin, United States - ProKatchers LLC
Description
Job Title: Document Control Specialist
Location: 95677, Rocklin, California, United States
Duration: 12 Months
Job Description:
