Documents Coordinator

Abbott Laboratories is seeking a Documents Coordinator to manage and control quality and regulatory documentation supporting biotech and pharmaceutical operations. In this role, you will maintain accurate, compliant records across product lifecycles, ensuring timely updates, version control, and secure access to critical documents. You'll support audits, inspections, and internal reviews, partnering with quality, regulatory, and operations teams. Abbott offers an inclusive, mission-driven culture, strong career development, global impact opportunities, and competitive benefits that support growth, learning, and work-life balance.

Responsibilities

• Maintain, organize, and control quality and regulatory documents for biotech and pharmaceutical operations
• Manage version control, approvals, and change history within electronic document management systems (EDMS)
• Ensure documentation complies with Gx
• P, FDA, ISO, and internal quality standards
• Coordinate document reviews, updates, and periodic revisions with cross-functional stakeholders
• Support internal and external audits and inspections by preparing and retrieving required documentation
• Monitor document workflows, access permissions, and archival processes to ensure data integrity
• Create, format, and maintain SOPs, work instructions, and related controlled documents
• Track documentation metrics and generate reports for quality and regulatory teams
• Train users on document control processes, templates, and system best practices
• Collaborate with quality, regulatory, and operations teams to continuously improve documentation processes

Required Skills

• Document control
• Quality management systems (QMS)
• Gx
• P/GLP/GMP compliance
• Regulatory documentation standards
• Version control and change management
• Electronic document management systems (EDMS)
• SOP creation and maintenance
• Data entry and records accuracy
• Audit support and inspection readiness
• Cross-functional communication