Senior Document Control Specialist

Location: San Diego, CA • Duration: 1 month (Contract)

About the Role

We are seeking a Senior Document Control Specialist to manage document control processes and change management functions within a highly regulated environment. In this role, you will lead the Document Change Order and Deviation workflows, ensure compliance with Good Documentation Practices (GDP), and maintain the site’s Quality Management System (QMS) documentation standards.

Responsibilities

• Serve as the facility's Change Order Coordinator: facilitate, format, track, route, and release Document Change Orders (DCOs) and Deviations independently and in a timely manner.
• Review new and updated documents to ensure all changes are justified, complete, accurate, compliant with Good Documentation Practices (GDP), and approved by required functional areas per established procedures.
• Issue document numbers, lab notebook numbers, and part numbers; manage document archiving, obsolescence, and physical/electronic storage.
• Assist in drafting, formatting, editing, and updating Standard Operating Procedures (SOPs) across the organization; ensure periodic document reviews are completed on schedule by Document Owners.
• Perform Document Control training for new and existing personnel; support the development of QA training materials, assist with training assignments and metrics collection, and trend Document Control metrics for Management Review.
• Support internal and external quality audits; drive continuous improvement initiatives within the Quality Management System, focusing on change order and document control workflows.
• Address queries and resolve issues raised by Document Owners and Approvers promptly across multiple departments.

Requirements

• Bachelor’s degree or an equivalent combination of education and industry experience.
• 2+ years of experience in Quality Assurance or Document Control within a laboratory, medical device, or similarly regulated industry.
• Working knowledge of 21 CFR 820 and ISO 13485:2016 standards.
• Hands-on experience processing document changes within an electronic Document Management System (eDMS); Agile PLM/DMS experience preferred.

Skills

• Highly proficient with Microsoft Office (Word, Excel, PowerPoint, Visio) and electronic document management software.
• Strong background in technical writing, document formatting, and data trending.
• Ability to thoroughly understand QMS procedures, identify deviations from documented processes, and maintain exceptional attention to detail.
• Self-motivated and capable of working independently to resolve document control challenges across cross-functional teams in a fast-paced environment.
• Clear, professional written and verbal communication skills in English.