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
Alexis Cabero
Branch Manager
As Branch Manager, Alexis Cabero oversees recruiting efforts across all divisions while spearheading the Legal and Healthcare divisions. She leads a team of recruiters and drives talent strategies that support a wide range of business needs. Alexis specializes in identifying top-tier professionals in accounting & finance, legal support, medical devices, administrative operations, customer service, engineering, and human resources.
A graduate of the University of California, Irvine with a B.A. in Arts and Digital Media, Alexis began her recruiting career in 2014 staffing assisted living facilities—matching compassionate healthcare professionals with clients who needed dedicated, non-medical personal care. Her experience has since expanded into high-volume recruiting, professional staffing, and niche talent acquisition, placing candidates in roles such as Staff Accountants, AP/AR Specialists, Payroll professionals, Legal Assistants, Paralegals, and other essential positions.
Alexis is passionate about helping individuals recognize and reach their full potential. She takes a consultative, personalized approach with every candidate, using a thorough discovery process to understand their strengths and align them with meaningful opportunities exclusive to Marquee Staffing.