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Document Control Specialist
hace 2 meses
The Document Control Specialist is responsible for developing, implementing, and managing document control systems to ensure accurate and efficient handling of organizational documentation. This role involves maintaining compliance with regulatory requirements, leading document control initiatives, and providing support and training to other team members.
A mid-level to senior-level position with a deeper focus on strategic document management and oversight, often involving leading document control initiatives and ensuring compliance with complex regulatory requirements.
Key Responsibilities- Document Management:
- Implement and maintain document control systems and procedures in compliance with the Quality Management System, AS9100/ISO 9001 standards and other relevant requirements.
- Maintain and organize physical and electronic documents to ensure easy retrievability, as well as maintain proper distribution, access, preservation, and retention.
- Review documents for accuracy, completeness, and compliance with standards.
- Facilitate and assist users with the document management processes from creation, review, approval, and release.
- Manage document versions and revisions.
- Maintain accurate records of document control activities and ensure data integrity.
- Create diagrams, charts, and other visual aids to enhance understanding of document control processes.
- Configuration Management & Change Control:
- Oversee and facilitate changes while following change control procedures to ensure that changes are properly documented and approved.
- Liaise with relevant departments to obtain necessary approvals and input for document changes.
- Advise on the impacts of changes to documentation and document control systems.
- Track and log all changes to documents, including revision history.
- Review Bills of Materials (BOMs) for accuracy across parts lists, work instructions, and drawings.
- Analyze and compare Bills of Materials and other product data to assist with configuration control and ensure streamlined and consistent documentation and workflows.
- Communicate document changes to all affected parties.
- Control serial numbers and serial number formats in the ERP database and ensure accuracy and consistency of labeling physical products.
- Regulatory Compliance:
- Ensure all documents comply with the Quality Management System, AS9100/ISO 9001 standards and other relevant requirements.
- Stay updated on industry regulations and standards related to document control.
- Prepare and provide documentation for audits and inspections and represent the document control function during these processes.
- Quality Assurance:
- Conduct thorough audits to ensure document integrity and regulatory compliance.
- Implement corrective actions for document discrepancies and process improvements.
- Collaboration and Communication:
- Coordinate with various departments to gather, review, process, and maintain documents.
- Work closely with engineering, manufacturing, and manufacturing engineering to gather information and understand product and documentation requirements.
- Serve as the primary contact for document-related inquiries and issues.
- Facilitate communication and provide training on document control procedures and relevant regulatory requirements.
- Participate in product development and change control meetings to provide input regarding documentation systems.
- Training and Support:
- Create, update, and maintain training materials, user guides, how-to manuals, and instructional videos to facilitate understanding of document control processes and systems.
- Conduct regular training sessions for new hires and ongoing training for existing staff to ensure understanding and adherence to document control procedures.
- Provide hands-on training and support to ensure all employees are proficient in using document control systems.
- Provide technical support and troubleshooting assistance to users experiencing difficulties with the document management system and software.
- Assist users with document creation, revision, and approval processes.
- Collect and analyze feedback from training sessions, audits, and other inputs to identify areas for improvement.
- Mentor junior document control staff and oversee their development.
- May assign and review day-to-day tasks for the Document Control Associate.
- High school diploma or GED required.
- Bachelor's Degree in Business Administration or similar major is preferred.
- Minimum of 3-5 years of experience in document control or records management.
- Understanding of AS9100 and ISO 9001 standards and regulatory requirements.
- Experience with electronic document management systems (EDMS).
- Experience in Configuration Management.
- Strong understanding of quality management systems and regulatory compliance.
- Excellent communication and interpersonal skills.
- Strong attention to detail and organizational skills.
- Proficiency in Microsoft Office Suite, Adobe Suite, and other document control software.
- Ability to work independently and manage multiple tasks simultaneously.
- Project management and problem-solving skills.
- Ability to write reports, business correspondence, and manuals.
- Strong task management and logic ability.
- Ability to participate in and facilitate group meetings.
- Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
- Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the public.
- Hearing and speaking to exchange information in person, on the telephone or virtually.
- Dexterity of hands, fingers, and wrist to operate a computer keyboard, calculator or assemble/manufacture intricate items.
- Seeing to read a variety of materials.
- Sitting or standing for extended periods of time.
- May need physical agility to lift 20 pounds to shoulder height.
- Physical agility to lift, carry, push, or pull objects.
Salary range for this position is $27.37-$30.00 Hourly