Document Control

General Description:

The QA Document Control Specialist is responsible for the maintenance of the Quality Assurance records and documentation.

Specific Responsibilities & Duties:

·        Promotes a safe working environment and adheres to Health, Safety and Environmental procedures, company safety rules, Current Good Manufacturing Practices (cGMP’s), and Standard Operating Procedures (SOP’s) at all times.

·        Verifies that each record is accurate and complete, in compliance with GMP practices.

·        Assembles Production Records by batch.

·        Ensures documentation is review and meets all required testing prior of releasing product in QAD.

·        Prepares Documentation for (B, M, E) samples prior to send to customer for review and approval.

·        Prepares and review Certificate of Analysis.

·        Reviews OTC production reconciliation.

·        Prepares and review Certificate of Manufacture.

·        Prepares labels for customer samples. 

·        Assists other departments when needed.

·        Tracks and reports FG OTC annual product review.

·        Replies/follows up with e-mails and/or customer requests.

·        Monitors releases in QC status for more than 5 days and provide feedback on status.

·        Reviews documentation and releases to ensure completeness and proper GDP documentation.

·        Gathers and collect information as needed from other departments.

·        Performs additional duties as instructed by QA Assurance Supervisor.

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