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 specifications to proper internal c...
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 specifications to proper internal c...
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