Document Control Specialist

Document Control Specialist is responsible for managing and maintaining all manufacturing-related documents and records within an PII. This role ensures that all documents are accurate, up-to-date, and easily accessible to authorized personnel. The Document Control Specialist plays a critical role in ensuring compliance with regulatory standards and quality management systems in the manufacturing environment. Job responsibilities include but not limited to:

• Coordinates with Engineering Management in the planning, project development, execution, and documentation of projects.
• Provides all engineering output necessary to produce the engineered product. Outputs include BOMs (Bill of Materials), engineering drawings, diagrams, and other documents detailing work instructions to the Production Department.
• Provides document gathering and generation as needed for products that are lacking in complete documentation.
• Prepares customer facing documentation and SDRL documents according to contract requirements.
• Establishes document numbering and tracking mechanisms.
• Monitors and supports the creation and distribution of Project BOMs, Change Control Documents, and Test Procedure documents.
• Engages in Project Management activities, product/component research and manufacturing support.
• Implement and manage the change control process for manufacturing documents. Evaluate change requests, assess their impact, and coordinate with relevant stakeholders to ensure proper implementation. Maintain a comprehensive change control log to track all document changes.
• Coordinate the review and approval process for manufacturing documents. Collaborate with subject matter experts, department heads, and other stakeholders to ensure accuracy, clarity, and compliance. Monitor document review cycles and ensure timely completion.
• Stay up-to-date with relevant regulations, industry standards, and quality management system requirements related to manufacturing documentation. Ensure that all manufacturing documents adhere to these standards and facilitate audits and inspections as required.
• Develop and deliver training programs to educate manufacturing personnel on Document Control processes, procedures, and best practices. Promote awareness and compliance with Document Control policies across the organization.dentify opportunities for process improvement within the Document Control function. Streamline document workflows, enhance systems, and propose efficiency initiatives to optimize document management processes.

Experience Needed:

• Creating technical documentation (schematic, assembly diagram, interconnect drawing, etc.)
• Strong understanding of Document Control principles, regulatory requirements, and quality management systems (e.g., ISO 9001, GMP, FDA).
• Excellent organizational and time management skills with the ability to prioritize tasks and meet deadlines.
• Attention to detail and a high level of accuracy in document management and data entry.

Proficient in using Document Control software and electronic document management systems.