Job Description

Who is CorDx？   

 

CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare.

 

Job Type: Full time
Job Title: Document Control Specialist
Location: Hybrid - San Diego

Salary Range: $70,000 - $75,000

Position Summary:

The Document Control Specialist is responsible for managing the flow and storage of all controlled documents within the organization. This role ensures that documents are accurate, up-to-date, and available to all employees who require them. The specialist will maintain the Master Control document management system, ensure compliance with regulatory requirements, and support continuous improvement initiatives related to document control.

Key Responsibilities:

• Document Management:
• Manage the creation, revision, distribution, and archiving of controlled documents, including SOPs, work instructions, forms, and other quality-related documentation.
• Ensure that all documents are properly labeled, indexed, and stored in the document management system (Master Control).
• Coordinate document review and approval processes, ensuring timely updates and compliance with internal procedures.
• Compliance and Quality Assurance:
• Ensure that all controlled documents comply with relevant regulatory standards (e.g., ISO 13485, FDA 21 CFR Part 820) and company policies.
• Participate in internal and external audits, providing document control support and ensuring that documentation is readily available for inspection.
• Assist in the development and maintenance of document control procedures, templates, and guidelines.
• System Administration:
• Maintain and administer the Master Control electronic document management system, ensuring user access is controlled and that the system is functioning effectively.
• Train staff on document control procedures and the use of the document management system.
• Monitor and track document changes, ensuring that version control is maintained and that obsolete documents are removed from circulation.
• Continuous Improvement:
• Identify opportunities for process improvements in the document control function and contribute to the implementation of best practices.
• Collaborate with other departments to streamline document workflows and enhance efficiency.
• Support the development and implementation of document control metrics to monitor system performance and compliance.
• Communication and Support:
• Act as the primary point of contact for document control inquiries, providing guidance and support to staff.
• Ensure effective communication of document updates and changes across the organization.

Requirements

• Education:
• Bachelor's degree in a relevant field (e.g., Quality Management, Regulatory Affairs, Business Administration) or equivalent experience.
• Experience:
• 2+ years of experience in document control, quality assurance, or a related role within a regulated industry (e.g., medical devices, pharmaceuticals, biotechnology).
• Familiarity with document management systems and quality management systems.
• Hands on experience with Master Control.
• Skills:
• Strong attention to detail and organizational skills.
• Excellent written and verbal communication skills.
• Ability to manage multiple tasks and prioritize effectively in a fast-paced environment.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and document management software.
• Knowledge of regulatory standards such as ISO 13485, FDA 21 CFR Part 820, and other relevant regulations.

Benefits

• Medical Insurance Plan
• Retirement Plan
• Paid Time Off

• Training & Development
  We are an equal-opportunity employer and celebrate diversity, recognizing that diversity of thought and background builds stronger teams. We approach diversity and inclusion seriously and thoughtfully. We do not discriminate on the basis of race, religion, color, ancestry, national origin, caste, sex, sexual orientation, gender, gender identity or expression, age, disability, medical condition, pregnancy, genetic makeup, marital status, or military service.

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