The document control coordinator is responsible for coordinating the system by which changes are made to test methods, material specifications, controlled forms, Standard Operating Procedures (SOP), and may include Batch Records. This includes maintaining the Test Numbering and Sequential Numbering databases, or SOP Index and Tracking databases; includes drafting forms, training guides, test methods and material specifications per PCR requirements or formatting SOPs within the Document Management System (DMS); finalizing approved (Process Change Requirements) PCRs or SOPs, ensuring impact assessment items are met or communicated, and ensuring copies are distributed to contract customers and Regulatory Affairs as needed. Responsible for preparation and maintenance of master test method, material specification and controlled form files or SOP files and maintaining various listings and templates.
Creates and assures content accuracy of new and changes to existing test methods, material specifications, training guides, and forms for quality manufacturing and testing of product and market availability.
Formats SOPs within the DMS and assures accuracy of the SOP summary of changes.
Coordinates and maintains raw material bills of materials.
Updates files as changes, deletions and new materials are issued.
Coordinates and maintains SOPs within the DMS.
Updates files as changes, deletions, and new SOPs are issued.
Assures correctness and completeness of product test methods, material specifications, training guides, and forms for the laboratories and production to comply with procedures, policies, regulations, and the manufacture of quality products.
Assures completeness of SOP summary of changes, properties, and format.
Maintains and publishes master listing of the following: Analytical Procedures, Standard Methods of Analysis, Material Specifications, and Controlled Forms; OR maintains all aspects of SOP numbering, routing, and reporting through DMS.
Maintains accurate and complete documents.
Performs other duties relating to QA Documentation or special projects as assigned by management for increased productivity within department.
Creates and maintains database tracking systems throughout the QA Documentation department.
May perform batch record or SOP drafting and assures accuracy of content.
Creates logbooks as requested.
Other duties as assigned.
1 to 3 years' experience with a minimum Associates degree in a science field.
Some experience in a GMP environment, preferably experience in the QA Documentation department.
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