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.