Job Description
POSITION PURPOSE AND SCOPE:
- The Document Control Specialist is responsible for supporting and maintaining the company’s compliance with applicable quality standards.
- This includes oversight of cGMP practices, quality systems, documentation, product labeling.
- This role is critical in ensuring products are safe, effective, and compliant with all regulatory requirements.
ESSENTIAL RESPONSIBILITIES:
- Review and approve all SOP’s, policies and cGMP documents.
- Review all Master Manufacturing Records, Batch Records, Test Records, and Supplier Specifications to ensure they meet federal or state regulations.
- Review and approve packaging records and finished product release documentation.
- Maintain specifications control, filings, and change history.
- Distribute quality system documents for review and authorization as required.
- Control and distribute all documents and...
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