Document Control Technician

*Job Title: Document Control Technician * *Location: Austin, TX 78728 * *Duration:12 Months* *Pay Rate:$22.83/hr.* *Shift Time: Day Shift* *Position Summary:* *Essential Duties & Responsibilities:* * Create, review, edit, route, implement, and archive Change Orders, SOPs, Work Instructions, Batch Records, and other controlled documents. * Coordinate the preparation and distribution of Batch Record packages through the Document Management System (DMS) based on manufacturing schedules. * Maintain the site documentation library, including validation packages, batch records, logbooks, controlled forms, and quality records. * Perform administrative reviews of validation packages and controlled documents to verify compliance with applicable SOPs and documentation requirements. * Review change control requests and ensure appropriate documentation, validation activities, and supporting records are properly linked and maintained. * Communicate with change initiators and stakeholders to verify that document content and change packages are complete, accurate, and compliant. * Implement approved document changes and Change Orders within the plant Document Management System. * Coordinate the receipt, review, tracking, issuance, and distribution of new and revised corporate policies, procedures, and specifications. * Manage logbook issuance, tracking, reconciliation, and record retention activities. * Coordinate periodic and biennial reviews of controlled documents to ensure they remain accurate, current, and compliant. * Maintain records management processes for documents stored onsite and at off-site archival locations. * Ensure timely creation and delivery of manufacturing, laboratory, quality, and scheduling documentation. * Assist with the preparation and writing of Standard Operating Procedures, Work Instructions, and other controlled documentation. * Ensure all documentation activities comply with cGMP, SOPs, plant policies, quality standards, and regulatory requirements. * Participate in documentation-related problem-solving activities and collaborate with manufacturing, quality, engineering, laboratory, and other plant departments. * Support departmental process improvement initiatives focused on documentation accuracy, efficiency, compliance, and record management. * Cross-train team members and provide guidance on document control and records management procedures as assigned. * Maintain accurate electronic and hard-copy records while ensuring documents are properly identified, controlled, stored, and retrievable. * Perform document comparisons and detailed quality checks to identify inconsistencies, missing information, formatting issues, or other documentation errors. * Prioritize multiple documentation activities and meet deadlines in a fast-paced manufacturing environment where priorities may change. * Perform other related duties and responsibilities as assigned. *Minimum Qualifications:* * Associate degree from an accredited college or university preferred/required. * Minimum of 1 year of applicable document control, quality, manufacturing, pharmaceutical, biotech, or related experience. * Alternatively, a high school diploma with 3+ years of experience in a quality or production role within a GMP-regulated environment. * Must be at least 18 years of age. * Experience in a regulated manufacturing or pharmaceutical/biotechnology environment is highly preferred. *Work Environment & Physical Requirements:* * Primarily sedentary office-based position within a professional manufacturing environment. * Regular use of computers, document management systems, and standard office equipment. * Requires flexibility to adjust or extend working hours when necessary to meet operational and customer requirements. * May occasionally require movement or lifting of documents, boxes, or other materials weighing up to 25 pounds. * Requires limited travel, typically less than 5%. * Position requires consistent attention to detail and the ability to make quality-related decisions based on written procedures and established documentation standards. *“We are an equal opportunity employer. It is our policy to provide employment, compensation, and other benefits related to employment without regard to race, color, religion, sex, gender, national or ethnic origin, disability, veteran status, age, genetic information, citizenship, or any other basis prohibited by applicable federal, state, or local law.”* COM1 Pay: $22.00 - $22.83 per hour Work Location: In person