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.

Please forward this posting to any friends or colleagues as we do offer a Referral Bonus for any candidate hired.

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