Document Control & Compliance Specialist

Ultimate Staffing Services; Anaheim (CA); On-site; USD 30,000 - 34,000; Full time

Job summary

Ultimate Staffing Services is recruiting for a Document Control Coordinator to maintain the quality system documentation lifecycle. You will ensure regulatory compliance, manage document versions, and control access within the ERP Change Control system in a fast-paced environment.

The role requires experience with electronic document management, GDP/GMP, and CFR 820.40. Strong cross-functional collaboration and attention to detail are essential for audits.

Qualifications

• Minimum two years or related experience in Document Control or Record Management preferred.
• Experience with electronic document management systems preferred.
• Experience in a Regulatory Medical Device Industry preferred.
• Good understanding of GDP, GMP, CFR 820.40, ISO 13485:2016 sections related to documents and records preferred.

Responsibilities

• Ensure all documents adhere to regulatory requirements, quality standards, and internal procedures.
• Scan, organize, and maintain both physical and digital documents, including archiving historical records.
• Manage users access, permissions, and system integrity within the internal ERP Change Control system.
• Schedules weekly and/or emergency CCB meetings as requested by internal departments.
• Review documents for formatting, compliance, and version control standards.
• Collaborate with cross-functional teams to facilitate document workflows, resolve issues, and ensure consistency in documentation practices.
• Maintain record retention timelines, ensuring documentation is accessible for audits.
• Process approved change controls in a timely manner, including updating information in internal ERP systems.
• Maintain internal Viewing System by adding current versions of controlled documents and removing historical revisions.

Skills

Document control

Regulatory knowledge

Cross-functional

MS Office

Engineering drawings

Audit readiness

ERP system

Tools

Electronic document management system

ERP Change Control

Job description

Ultimate Staffing Services is recruiting for a Document Control Coordinator to maintain the quality system documentation lifecycle. You will ensure regulatory compliance, manage document versions, and control access within the ERP Change Control system in a fast-paced environment.

The role requires experience with electronic document management, GDP/GMP, and CFR 820.40. Strong cross-functional collaboration and attention to detail are essential for audits.