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- 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.
- 8 hour shift
- In-person
Quality Assurance Specialist - Rocklin, United States - Rang Technologies Inc.
Description
*Description:*Minimum education: HS degree or GED**Translate/ Review docs in 22 languages using translation tools such as google translate.
*Confirming docs are translated correctly**Experience with translation industry**Excellent communication skills*• Participate in projects/assignments that support continuous improvement efforts and department/company goals especially as they relate to translation projects
Job Type:
Contract
Pay:
$ $30.00 per hour
Schedule:
Work setting:
Work Location:
In person