Document Control Specialist

Overview

Johnson & Johnson is currently recruiting a Document Control Specialist, Quality Assurance! This position will be located in Milpitas, California.

The Document Control Specialist is responsible for supporting the administration, maintenance, and monitoring of Quality Management System (QMS) documentation, training records, and change control activities in compliance with FDA Quality System Regulations (21 CFR Part 820), ISO 13485, company policies, and other applicable regulatory requirements.

This role supports document control operations, assists with continuous improvement initiatives, and works with cross-functional teams to ensure the accuracy, accessibility, and compliance of controlled quality records and documents.

Participate in cross-functional teams to support product launch requirements and targets. Recommend and implement appropriate change control systems and processes to endure effective compliance to JJSV and external regulations.

Adheres to environmental policy, procedures, and supports department environmental objectives.

Key Responsibilities:

• Support the administration, maintenance, and monitoring of document control, training, and change control processes in compliance with FDA/QSR, ISO 13485, company procedures, and applicable regulatory requirements.
• Process and maintain controlled documents and quality records, ensuring accurate and timely review, approval, release, distribution, implementation, retention, and archival.
• Support document changes, periodic reviews, document lifecycle activities, and management of controlled document repositories within electronic systems such as Agile and SAP.
• Coordinate documentation activities and support Technical Review Board (TRB) meetings, change control workflows, and document control-related projects.
• Collect, compile, and prepare monthly and quarterly document control metrics, including periodic review status, change request backlog, document processing cycle times, and training compliance data.
• Assist in tracking and monitoring document control performance indicators and communicate status updates to management and stakeholders.
• Participate in cross-functional teams supporting product launches, process improvements, and quality system initiatives.
• Provide guidance and training to employees on document control procedures, document management systems, and approved quality system processes.
• Draft, revise, and maintain SOPs, work instructions, forms, and other controlled documents under the direction of Quality Assurance management.
• Support continuous improvement activities by identifying opportunities to improve document control processes, efficiency, and compliance.
• Assist with internal audits, external audits, and regulatory inspections by preparing, organizing, and retrieving controlled documentation and quality records.
• Coordinate filing, storage, retrieval, retention, and disposition of controlled documents and records, including off-site storage activities when applicable.
• Communicate document control issues, compliance concerns, and process improvement