Document Control Specialist

Job Title: Document Control Specialist

Job Description

We are seeking a meticulous and highly organized Document Control Specialist to join our team. In this role, you will be responsible for managing the lifecycle of controlled documents and records, ensuring compliance with regulatory standards and internal quality systems. You will play a key role in maintaining the integrity, accessibility, and security of documentation across the organization.

Key Responsibilities

• Log and track incoming records and logbooks in the designated record location database, ensuring accurate metadata and traceability.
• Prepare physical and digital records for repository storage, including classification, labeling, and filing in assigned secure locations.
• Monitor and manage the record request inbox, processing withdrawal requests, issuing distribution notifications, and maintaining audit trails.
• Execute comprehensive archival processes, including document preparation, inventorying, and coordination of internal and offsite storage logistics.
• Train cross-functional personnel on document authoring standards, reviewer/approver workflows, and best practices within the Document Management System (DMS).
• Serve as a DMS administrator, overseeing the creation, revision, and lifecycle management of document templates and controlled quality documents.
• Review documents for Good Documentation Practices (GDP) compliance, ensuring adherence to formatting standards and regulatory requirements.

Document Systems & Compliance

• Manage the publishing and release process of controlled documents in DMS to support operational and regulatory initiatives.
• Oversee archival expansion projects, including layout execution, departmental training, and post-renovation support.
• Administer REAL and Veeva EDMS platforms, including configuration, user support, and periodic review cycles.
• Ensure seamless integration of EDMS content with Learning Management Systems (LMS) for training and knowledge transfer.
• Support global SOP governance by managing the Global DCC SOP, escalating inquiries, and assisting with compliance assessments.
• Coordinate the distribution and reconciliation of project-related documents, ensuring timely returns and accurate recordkeeping.
• Generate and publish DCC performance metrics on a monthly, quarterly, and annual basis for internal reporting and audits.

Essential Skills & Qualifications

• Minimum 5 years of experience in Electronic Document Management Systems (eDMS) with a strong understanding of workflow execution.
• In-depth knowledge of GxP-compliant document control practices, including document lifecycle management and regulatory documentation.
• Proven experience in records management, archival processes, and issuance of controlled logbooks.
• Strong computer literacy with exceptional attention to detail and accuracy in data entry and document handling.
• Excellent communication and organizational skills, with the ability to manage multiple priorities and stakeholders.
• Proficient in time management and document version control within quality systems.
• Experience training users and troubleshooting document control systems and processes.

Preferred Qualifications

• Hands-on experience with REAL and/or Veeva eDMS platforms.
• Experience in clinical, research, or pharmaceutical environments with exposure to FDA-regulated documentation.
• Technical writing experience in a scientific or regulated setting.
• Proficiency in Microsoft Office Suite, including Word, Excel, Visio, and Project.
• Familiarity with CAPA processes and document-related compliance investigations.

Work Environment

• Full-time, on-site position within the Quality Assurance Department.
• Monday to Friday, 1st shift schedule.
• Collaborative work environment with cross-functional exposure to FDA-approved projects, including innovative treatments for bladder cancer.