Document Control Specialist

Job Description

Job Description

The Document Control Specialist contributes to meeting Langham goals of exceptional customer service, quality, process improvement, and profitability by managing and maintaining the document management system for Langham Logistics. This role ensures that all regulatory, quality, and operational documents are properly created, reviewed, approved, updated, and archived in compliance with cGMP, GDP, FDA, and client requirements.

The Document Control Specialist plays a critical role in supporting regulatory compliance, audit readiness, and continuous improvement initiatives.

Key Outcomes Expected

• Manage the creation, revision, approval, and distribution of SOPs, work instructions, policies, quality agreements, and other controlled documents.
• Maintain the document control system ensuring all documents are current, properly versioned, and accessible to authorized personnel.
• Ensure compliance with cGMP, GDP, FDA, ICH, and client-specific requirements for document management.
• Support internal audits, client audits, and regulatory inspections by providing accurate and complete documentation.
• Monitor document expiration and review cycles; facilitate timely updates and approvals.
• Assist quality and operations teams in drafting, formatting, and reviewing new or revised documents.
• Track and report on document control metrics to support management review and continuous improvement.
• Train associates on document control procedures and ensure compliance with established standards.
• Maintain proper archiving and retrieval procedures for historical and regulatory documentation.

Education and Experience

Preferred Skills :

Physical Demands

Work Environment

This role operates in a regulated warehouse and office environment, including areas handling temperature-sensitive biologics and vaccines. Some interaction with operational teams may be required, but this is primarily an office-based role. Occasional travel may be required for audits or client meetings.

Disclaimer

This job description is not intended to be all-inclusive. This position may be required to perform other related duties assigned to meet the ongoing needs of the organization. Langham reserves the right to modify job responsibilities and expectations as business demands evolve.

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