Document Control Specialist

Prismatik • Irvine, CA

43d • $23 - $25 • Onsite

About The Position

The Document Control Specialist is responsible for maintaining all Engineering and Product Development records to ensure integrity and accessibility. This role involves processing and controlling the storage of Quality Records, interacting with users of controlled documentation, and managing review and approval workflows in an electronic document management system. The specialist will ensure document format compliance with Good Documentation Practices (GDPs), assist with FDA inspections and audits, and track documentation review and implementation. Key duties include distributing documents, ensuring accurate database entries with self-auditing, analyzing change requests, and providing clerical and administrative support related to documentation processes. The role also involves creating and maintaining document templates, routing and releasing documentation, and following up on training requirements. Additionally, the specialist will manage the document archival room, assist with training programs, and collaborate with internal teams to ensure receipt of training materials. This position performs other related duties and projects as business needs require.

Requirements

• High school diploma or equivalent.
• Minimum two (2) years of experience in dental or medical device industry.
• Minimum one (1) year of customer service experience.
• Proficient skills in the MS Office Suite (Word, PowerPoint, and Outlook); advanced proficiency in Excel.
• Demonstrated knowledge of document control fundamentals, quality systems, and Good Manufacturing Practice (GMP) requirements.
• Demonstrated understanding of current medical device industry and applicable regulations.

Responsibilities

• Maintains all Engineering and Product Development records to ensure integrity and accessibility including but not limited to photocopying and scanning documents.
• Processes and controls storage of Quality Records.
• Interacts directly with users of controlled documentation to ensure internal conformance to company quality control requirements.
• Processes review and approval workflows in electronic document management system.
• Reviews document format to ensure compliance to Good Documentation Practices (GDPs).
• Assists in Food and Drug Administration (FDA) inspections and Notified Body audits regarding marketed products, as requested.
• Tracks and facilitates timely documentation review and implementation.
• Distributes documents in accordance to control procedures.
• Ensures accurate and timely input of database entries; implements a self-auditing system to verify work.
• Analyzes change requests for completeness.
• Provides support to internal customers with documentation needs.
• Updates electronic document profiles to reflect appropriate changes.
• Provides clerical and administrative support related to documentation processes and systems.
• Creates and maintains document templates by coding fields and uploading into the electronic document management system.
• Routes and releases documentation.
• Follows up on training requirements to ensure compliance to the department’s standard operating procedures.
• Assists with monitoring the Document Control email inbox to ensure all requests are assigned and responded to in a timely manner.
• Communicates among the Document Control team to ensure request are fully completed.
• Maintains the document archival room; ensures files are accurate and easily retrievable.
• Assists with training program by filing training records and logging training.
• Works with a variety of internal teams to ensure receipt of training materials.
• Performs other related duties and projects as business needs require at direction of management.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED