Position Title: Document Control SpecialistReports to: Production ManagerDepartment: ProductionDate Revised: March 2013FLSA Status: Non-Exempt (hourly)Summary:
This position oversees the preparation, control, and flow of documents of all Productionprocesses by working closely with the Regulatory and Quality Assurance departments. This positionmaintains a comprehensive system to ensure that all users have access to the latest revision of appropriate documentation. This position ensures that documentation is in place to controlmanufacturing processes, resulting in a quality end product in conformance with USDA regulations. Theincumbent will serve as the backup to the Production Administrative Assistant.
Duties and Responsibilities:
Works closely with all areas of Production and the Quality Assurance Department in the creation,review, revision, submission, completion and coordination of all related documents, including but notlimited to, Standard Operating Procedures (SOPs), Manufacturing Directions, Outlines of Production(OOP), Change Controls, Corrective Actions, Root Cause Analysis.
Prepares and maintains Standard Operating Procedures (SOPs) directly related to the Productionprocess. Actively coordinates the preparation and maintenance of these SOPs with the Quality Assurance Department.
Works closely with Regulatory Affairs Associates regarding Outlines of Production USDA/APHIS (asper Code of Federal Regulations, title 9, parts 1 – 199) and internal requirements. Ensures that alldocuments, Manufacturing Directions and SOPs align with the Outlines of Production. Immediatelynotifies Regulatory Affairs Associates of any deviations.
Manages a system to ensure that paperwork flows in and out of department in an efficient andcontrolled manner; follows up as needed with Section Leaders, assists with Root Cause Analysis forany process deviations, and helps to ensure that paperwork is submitted timely and accurately.
Maintains documentation error spreadsheet for Section Leaders and Production Manager. Submitsmonthly report on documentation errors within each section of Production.
Immediately notifies Production Manager of any processes that are not in conformance with the SOP.Works with the Manager, Director, and Process Improvement to complete the appropriate paperwork to request a change to our documents.
Understands and applies quality guidelines and regulatory/compliance requirements relative to allduties assigned to this position.
Assists the Production Manager and Section Leaders in fostering a departmental focus on qualityprocesses, paperwork, and products.
Assists the PI Specialists and/or Section Leaders in identifying and tracking Manufacturing Directionsfor update. Notifies the appropriate parties of manufacturing directions that need to be updated andfollows up on the progress.
Acts as backup to the Production Administrative Assistant.
Other duties as assigned.