QA Specialist

Responsibilities:

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.