Senior Document Control Specialist

About the Role

This is a 3+ month contract position located in San Diego, CA. The Senior Document Control Specialist will serve as the Change Order Coordinator for the facility, managing document control processes in a regulated industry environment.

Responsibilities

• Facilitate Document Change Orders and Deviations, including formatting, coordinating review and approval, tracking, routing, and timely release of controlled documents.
• Ensure new or revised documents are appropriate, justified, accurate, complete, compliant with Good Documentation Practices, and approved by required functional areas.
• Issue document numbers, lab notebook numbers, and part numbers.
• Draft, format, edit, and rewrite SOPs to support quality systems across the organization.
• Ensure timely periodic document reviews by Document Owners.
• Manage archiving, obsolescence, and document storage.
• Provide Document Control training for new and existing employees.
• Support development of QA-related training materials, including training assignments and collection of training metrics in Metro.
• Trend Document Control Metrics for Management Review.
• Respond to queries and issues from Document Owners and Approvers in a timely manner.
• Assist with internal and external audits.
• Support continuous improvement of the Quality Management System, with a focus on document control and change order processes.

Requirements

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

Skills

• Proficient with Microsoft Office (Word, Excel, PowerPoint), electronic document control tools, and Visio.
• Ability to understand QMS procedures and recognize deviations from approved documented procedures.
• Self-starting, detail-oriented, and able to focus on tasks in a fast-paced, team-oriented environment.
• Strong written and verbal communication skills in English.
• Ability to work independently and resolve Document Control issues across multiple departments.

Benefits

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking, and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital Coverage, and Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k)