Senior Document Control Specialist

Document Control / Change Order Coordinator

Pay: $30-$35/hour
Duration: 1 month initially
Location: Onsite in San Diego, CA

Position Summary

The Document Control / Change Order Coordinator will support Quality Assurance and Quality Management System (QMS) activities, with a primary focus on document control, change orders, deviations, controlled documentation, and training. This position will work cross-functionally to ensure documents are accurate, compliant, properly reviewed and approved, and released in accordance with established procedures and applicable regulatory requirements.

Responsibilities

• Serve as the facility's Change Order Coordinator .
• Independently facilitate Document Change Orders and Deviations , including document formatting, review and approval coordination, tracking, routing, and timely release of controlled documents.
• Review new and revised documents to ensure changes are appropriate, justified, accurate, complete, compliant with Good Documentation Practices (GDP) , and approved by required functional areas.
• Issue document numbers, laboratory notebook numbers, and part numbers .
• Assist with drafting, formatting, editing, and rewriting Standard Operating Procedures (SOPs) supporting organizational quality systems.
• Coordinate periodic document reviews with Document Owners and ensure reviews are completed on schedule.
• Manage document archiving, obsolescence, and storage .
• Conduct Document Control training for new and existing employees.
• Support development of Quality Assurance training materials .
• Assist with training assignments and collection of training metrics in Metro .
• Track and trend Document Control metrics for Management Review.
• Respond to questions and resolve issues raised by Document Owners and Approvers.
• Support internal and external audits .
• Contribute to continuous improvement of the Quality Management System (QMS) , with particular focus on document control and change order processes.

Basic Qualifications

• Bachelor's degree and/or equivalent combination of education and relevant experience.
• 2+ years of Quality Assurance and/or Document Control experience within a laboratory, medical device, or similarly regulated environment.
• Working knowledge of 21 CFR Part 820 and ISO 13485:2016 .
• Experience processing document changes using an electronic document management/document control system .
• Experience with technical writing, document formatting, and data trending .
• Experience with Agile Document Management System preferred.

Technical Skills

• Microsoft Word
• Microsoft Excel
• Microsoft PowerPoint
• Microsoft Visio
• Electronic Document Control / Document Management Systems
• Quality Management Systems (QMS)
• Document Change Orders
• Controlled Documentation
• SOPs
• Good Documentation Practices (GDP)
• 21 CFR Part 820
• ISO 13485:2016

Competencies

• Strong understanding of QMS procedures and ability to identify deviations from approved procedures.
• Detail-oriented, organized, and self-directed.
• Ability to work independently while coordinating with multiple departments.
• Ability to manage multiple priorities in a fast-paced, team-oriented environment.
• Strong written and verbal English communication skills.
• Strong problem-solving skills related to Document Control and QMS processes.

If you are interested in hearing more about the position, please respond to this posting with your resume attached.

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