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Document Control Specialist Production Manager Production March 2013 Non-Exempt (hourly)
Summary: This position oversees the preparation, control, and flow of documents of all Production processes by working closely with the Regulatory and Quality Assurance departments. This position maintains 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 control manufacturing processes, resulting in a quality end product in conformance with USDA regulations. The incumbent 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 not limited 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 Production process. 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 (as per Code of Federal Regulations, title 9, parts 1 – 199) and internal requirements. Ensures that all documents, Manufacturing Directions and SOPs align with the Outlines of Production. Immediately notifies Regulatory Affairs Associates of any deviations. Manages a system to ensure that paperwork flows in and out of department in an efficient and controlled manner; follows up as needed with Section Leaders, assists with Root Cause Analysis for any process deviations, and helps to ensure that paperwork is submitted timely and accurately. Maintains documentation error spreadsheet for Section Leaders and Production Manager. Submits monthly 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 all duties assigned to this position. Assists the Production Manager and Section Leaders in fostering a departmental focus on quality processes, paperwork, and products. Assists the PI Specialists and/or Section Leaders in identifying and tracking Manufacturing Directions for update. Notifies the appropriate parties of manufacturing directions that need to be updated and follows up on the progress. Acts as backup to the Production Administrative Assistant. Other duties as assigned.
Document Listing: SOPs Manufacturing Directions Outlines of Production (OOP) Change Controls Corrective Actions Root Cause Analysis
Qualifications: Must have a minimum of a high school diploma or equivalent with two (2) years of experience in document management and/or quality. Must be highly organized, detail oriented and possess excellent demonstrated oral and written communication skills. A general knowledge of the Code of Federal Regulations, title 9, Parts 1 - 199 (USDA vaccine regulations) is desirable. A working knowledge of SOP’s and skill in maintaining official documentation in regard to the aforementioned regulations is highly preferred. Must be proficient in computers, with prior experience in Microsoft Word and Excel. Attention to detail and the ability to organize and prioritize work and meet deadlines required. Effective interpersonal skills and ability to work collaboratively across diverse teams; able to foster cooperation in others. The incumbent is expected to communicate and perform professionally at all times; discretion and confidentiality is a must.
Note: All LAHI job descriptions are guidelines to assist employees in awareness of qualifications and performance expectations for their respective positions. It is not possible or desirable to commit every detailed aspect of each job to a written description. Each employee is expected to continually improve their knowledge and understanding of their job requirements and to use this information to increase insight as to the scope of their responsibilities. Job descriptions alone cannot be used as an argument to refuse work assignments.