Job Description

Position Summary

The Document Control Specialist will be responsible for managing, organizing, and tracking all documents to ensure compliance with industry standards and internal policies. This role involves coordinating document creation, revision, distribution, and archiving while maintaining accurate records in the electronic Quality Management System (QMS) and ensuring DOT compliance.

Key Responsibilities

• Manage the document control process, including creation, review, approval, distribution, and archiving of documents.
• Ensure all documents comply with company policies and regulatory requirements.
• Maintain and update the document management system for easy retrieval and reference.
• Collaborate with various departments to gather and prepare documentation for projects, audits, and inspections.
• Conduct regular audits of document control processes to identify areas for improvement.
• Provide training and support to staff on document control procedures and tools.
• Assist in developing and maintaining document control procedures and best practices.
• Generate reports on document status and compliance for management review.
• Facilitate the flow of information between teams and stakeholders regarding document updates and revisions.
• Create and distribute Batch Record packages via the electronic QMS according to manufacturing schedules.
• Oversee the documentation library, including issuing, receiving, and tracking validation packages, batch records, and logbooks.
• Adhere to Good Manufacturing Practices (GMP), procedures, and policies.
• Participate in problem-solving tasks and collaborate with various disciplines to ensure timely document creation and delivery.
• Oversee the biennial review process for controlled documents and manage records related to local and off-site document storage.
• Act as a Subject Matter Expert or cross-train other staff in documentation control as needed.

Qualifications

Preferred Education

• Associate’s degree or equivalent (60 college credit hours) with 2 years of relevant experience, OR
• High School Diploma (or equivalent) with 4+ years of experience in a quality or production-related role within a GMP environment.

Experience

• Proven experience in document control or records management, preferably in the pharmaceutical industry.
• Strong attention to detail and organizational skills.
• Proficiency in document management systems and Microsoft Office Suite.
• Excellent written and verbal communication skills.
• Ability to work independently and collaboratively in a team environment.

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