Document Control Specialist

Job Title: Document Control Coordinator

Company: Intellectt Inc.

Location: San Diego, CA

Employment Type: Contract

Duration: 6 months

Salary / Rate: $25/hr-$28/hr on W2

Job Summary

We are seeking a detail-oriented Document Control Coordinator to support document management, change control, and quality system activities within a regulated environment. The ideal candidate will have experience in Quality Assurance or Document Control, knowledge of applicable quality standards, and the ability to coordinate document reviews, approvals, revisions, and releases while maintaining compliance with established procedures.

Responsibilities

• Serve as the facility's Change Order Coordinator.
• Coordinate Document Change Orders and Deviations, including document formatting, review and approval workflows, controlled document tracking and routing, and timely document release.
• Ensure new and revised documents are justified, accurate, complete, compliant with Good Documentation Practices, and approved by the appropriate functional areas.
• Assign document numbers, laboratory notebook numbers, and part numbers.
• Draft, format, edit, and revise Standard Operating Procedures (SOPs) to support organizational quality systems.
• Coordinate periodic document reviews with Document Owners and manage document archiving, obsolescence, and storage.
• Conduct Document Control training for new and existing employees.
• Support the development of Quality Assurance training materials.
• Assist with training assignments and collection of training metrics in Metro.
• Track and analyze Document Control metrics for Management Review.
• Respond promptly to questions and issues raised by Document Owners and Approvers.
• Support internal and external audits.
• Contribute to continuous improvement of the Quality Management System (QMS), with a focus on document control and change order processes.

Required Qualifications

• Bachelor's degree or an equivalent combination of education and experience.
• At least 2 years of experience in Quality Assurance or Document Control within a laboratory, medical device, or similarly regulated industry.
• Working knowledge of 21 CFR Part 820 and ISO 13485:2016.
• Experience processing document changes through an electronic documentation management system.
• Experience in technical writing, document formatting, and data trending.
• Proficiency in Microsoft Office applications, including Word, Excel, and PowerPoint, as well as electronic document control tools and Visio.
• Ability to interpret QMS procedures and identify deviations from approved documented procedures.
• Strong written and verbal English communication skills.
• Ability to work independently, manage multiple priorities, and collaborate with cross-functional teams in a fast-paced environment.
• Strong attention to detail, initiative, and the ability to remain focused on assigned tasks.

Preferred Qualifications

• Experience with the Agile Document Management System.
• Experience supporting document control processes, change orders, and quality system activities in a regulated environment.

Work Requirements

• Work Schedule: 9:00 AM–5:30 PM.
• Ability to work effectively in a fast-paced, team-oriented environment.
• Ability to coordinate document control activities with multiple departments and resolve documentation-related issues.

Equal Employment Opportunity (EEO)

The employer is committed to providing equal employment opportunities to all qualified applicants and employees in accordance with applicable federal, state, and local laws.

Benefits

Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements:

Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.

Retirement Benefits: A 401(k)-retirement savings plan is available. No employer matching or other employer contributions are provided.

Paid Time Off (PTO): No PTO other than that required by applicable state and local laws

Application

Interested candidates who meet the qualifications are encouraged to apply with an updated resume highlighting their experience in Document Control, Quality Assurance, electronic documentation systems, and regulated quality environments.