Document Control Specialist, Quality

Overview

• Support daily operations of document management, ensuring compliance with GxP standards and lifecycle management.
• Collaborate with the Document Control team to maintain and improve documentation processes.
• Handle issuance, reconciliation, and archival of controlled documents and records.
• Provide on-site support at designated manufacturing and quality control locations.
• Ensure adherence to GDP and cGMP principles during daily activities.
• Contribute to internal and external audits by preparing and retrieving documentation.
• Assist in organizing and managing electronic and paper-based archival processes.
• Communicate effectively to assess and prioritize interdepartmental needs.

Key Responsibilities & Duties

• Adhere to established Standard Operating Procedures and Work Instructions.
• Manage activities related to document storage at designated facilities.
• Organize and file documentation for archival purposes.
• Support issuance and reconciliation of controlled documents.
• Retrieve documentation upon internal customer request.
• Provide assistance during audits and inspections, ensuring document readiness.
• Collaborate with SMEs to ensure compliance with industry regulations.
• Maintain high ethical standards and professionalism in daily tasks.

Job Requirements

• Bachelor’s Degree in science, engineering, or related discipline required.
• 1-4 years of experience in Quality within pharmaceutical or biotech industries preferred.
• Proficiency in document control and electronic document management systems.
• Strong organizational skills and attention to detail essential.
• Knowledge of cGMP principles and pharmaceutical regulations advantageous.
• Proficient in Microsoft Excel, Word, and PowerPoint.
• Ability to work independently, prioritize tasks, and manage multiple responsibilities.
• Effective collaboration and teamwork with internal and external stakeholders.