Document Control Specialist, Quality

Document Control Specialist, Quality Overview The Document Control Specialist, Quality will manage GxP documentation lifecycle processes, focusing on issuance and reconciliation, ensuring compliance with industry standards. Collaborate with the Document Control team to support daily operations and process improvements for document management systems. Maintain and organize high volumes of documentation in both electronic and paper-based formats, ensuring accessibility and accuracy. Provide support during internal and external audits, ensuring all documentation meets regulatory standards and guidelines. Act as a key resource for document control activities at the Gene Therapy Manufacturing Facility (GTMF). Ensure compliance with GDP and cGMP principles in all document management activities. Communicate effectively with internal departments to prioritize and address documentation needs. Document Control Specialist, Quality Key Responsibilities & Duties Adhere to Standard Operating Procedures and Work Instructions for document management processes. Manage document storage activities at the GTMF and GTQC facilities, ensuring proper archival and retrieval. Organize and file documents systematically for easy access and compliance with regulatory requirements. Support the issuance, reconciliation, and retention of controlled documents and records. Assist in preparing for audits and inspections by providing necessary documentation and support. Collaborate with internal and external subject matter experts to ensure documentation accuracy and compliance. Maintain high ethical standards and professionalism in all document control activities. Document Control Specialist, Quality Job Requirements Bachelor’s Degree in a science, engineering, or related discipline is required. 1-4 years of experience in Quality within the pharmaceutical, biotech, or life-sciences industry preferred. Proficiency in document control systems and electronic document management tools. Strong organizational skills and attention to detail are essential for success. Knowledge of cGMP and GDP principles is highly desirable. Proficient in Microsoft Excel, Word, and PowerPoint for documentation tasks. Ability to work independently and manage multiple tasks effectively. #J-18808-Ljbffr Greenkey Resources LLC