Document Control Coordinator
26 Technology Drive Irvine, CA 92618 US
Job Description
The Document Control Coordinator I, II, III is responsible for collecting, maintaining, archiving, and retrieving all documents necessary to ensure compliance with company procedures and FDA regulations. The Document Control Specialist monitors production operations to ensure that all users have the latest accurate revision of appropriate documentation in a timely manner.
General Description and Duties:
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Quality Systems: Maintain and improve company quality systems in compliance with FDA, International Standards (ISO), Canadian, and other regulatory agencies. This function is responsible for supporting company quality compliance and to provide control of processes, materials, and products in compliance with the company Quality System.
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Document Control:
- Works in Document Control for managing documents while ensuring quality, accuracy, and integrity of the hardcopies as well as electronic files.
- Comply with quality record retention, safeguard information, and retrieve the quality records more effectively.
- Executes routine DCO change packages (e.g., process redlines, proofread, make corrections, and document training). Assign part and document numbers.
- Provides guidance to other departments during the document change process.
- Maintains control of electronic and hard copy for SOPs, product drawings, labeling, artwork, process validation, manufacturing procedures, design control, marketing and educational material and test reports.
- Informs Vendors and Staff of document updates and provides controlled copies when applicable.
- Uses GDP (Good Documentation Practices) to correct records or assist others in correcting records.
- File, store, manage and track company documents for the Quality Management System.
- Performs scanning, filing, copying to maintain documents and obsolete inactive or older revision documents.
- Helps product development team maintain drawings, work orders, DCOs, etc.
- Perform administrative tasks as required.
- Releases DCOs, updates logs and lists.
- Reviews documentation for completeness.
- Files, organizes, archives, releases documentation both as hardcopy and electronic files.
- Consult with engineering, operations, and other cross-functional teams for documentation requirements.
- Verifies completeness of the DCO requirements prior to release of documents into QMS.
Meet Your Recruiter
Erika Castro
Recruiter
Erika Castro is a recent graduate from Chapman University, where she majored in Sociology and minored in Latinx and Latin American Studies. As a Recruiter at Marquee Staffing, she specializes in manufacturing and production roles within the medical device industry. Her previous recruiting experience involved working for the state of California to fill open seasonal positions.
In her free time, Erika enjoys hiking the nearby hills, traveling to San Francisco and Mexico, and reading the newest book that has caught her interest.