Quality Document Control Specialist I

About the Role

The Quality Document Control Specialist I supports Integra Mission Critical’s quality and engineering operations by managing and maintaining controlled documentation in accordance with company standards and regulatory requirements. This role ensures the accuracy, accessibility, and integrity of documents throughout their lifecycle, supporting compliance with Good Documentation Practices (GDP), Good Manufacturing Practices (GMP), and ISO standards. This position serves as an entry-level contributor responsible for document control administration, training support, and data integrity, while working closely with Quality, Engineering, and Operations teams to ensure documentation supports efficient and compliant manufacturing processes.

Key Responsibilities

• Administer document control processes, including document creation, revision, distribution, and archival, ensuring proper version control and accessibility across systems.
• Manage document repositories and maintain controlled lists.
• Support document lifecycle activities such as Document Change Requests, change control, and approval workflows.
• Ensure compliance with GMP, GDP, and company procedures by reviewing documentation for accuracy, completeness, and adherence to standards.
• Support the maintenance of quality documentation including SOPs, work instructions, specifications, test methods, inspection records, CAPAs, and training records.
• Assist in maintaining document management systems, including SharePoint or other electronic systems, ensuring data integrity and proper storage of files.
• Support training efforts by assisting in the development of materials, maintaining training records, and helping employees understand documentation processes.
• Collaborate with Engineering and Production teams to support technical documentation, including BOM updates, drawing management, and document indexing.
• Support ERP/PLM systems (such as Costpoint) by updating specifications and assisting with engineering release and change control processes.
• Support vendor documentation lifecycle management, including receipt, review, tracking, and final compilation of documentation.
• Generate reports, manage data entry tasks, assist with audits, and support special projects.

Requirements & Tech Stack

• Basic understanding of document control, quality systems, and compliance practices.
• Familiarity with GMP, GDP, or ISO standards preferred.
• Ability to manage document lifecycle and version control processes.
• Strong attention to detail and organizational skills.
• Ability to interpret technical documents and procedures.
• Strong communication and collaboration skills.
• Ability to manage multiple priorities in a structured environment.