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QA Specialist
4 months ago
- Oversee revision, development and tracking of controlled documents.
- Manage full life cycle of all controlled documents in the EDMS system including document creation, archival, and revisions.
- Maintain all document management files in the EDMS system.
- Responsible for issuing batch records, logbooks, and other controlled forms/documents.
- Collaborate with clients, QA team and other departments to assist in the revision, issuance of the documents.
- Assist with distributing tracking numbers for the quality systems.
- Handle all quality systems fundamentals including batch release, batch record review, batch record issuance, and all document control activities.
- Review documents for accuracy, completeness, and compliance.
Requirements:
- 2+ yeas of document control/document management experience working in an FDA regulated industry (biotechnology, pharmaceutical, medical device, etc.)
- Strong experience working with Electronic Document Management Systems (EDMS) such as Master Control, Veeva, Agile
- Bachelor's degree in science related field.
