Document Control Coordinator

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

JOB TITLE:

Document Control Coordinator

Pay Range: $22 - $25 based on education and experience

Temp to Hire Mon- Fri 8:00 am - 4:30 pm

PRIMARY OBJECTIVE:

Maintains the Sechrist Quality System Documentation, including procedures for document creation, review, approval and archiving. Tracks and controls documents throughout their lifecycle, ensuring proper versioning, access control, and security. Sustaining the Change control process through the internal ERP system.

ESSENTIAL DUTIES AND 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 assessable in a timely manner for internal and external audits.
• Process approved change controls in a timely manner, this includes updating information in the internal ERP systems
• Maintain internal Viewing System by adding current versions of controlled documents and removing historical revisions.

REQUIRED 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 Good Documentation Practice, (GDP), Good Manufacturing Practice, (GMP), Code of Federal Regulations Section 820.40 (Document Control), and ISO 13485:2016 Section 4.2.3, (Medical Device File/Medical Device Records, 4.2.4 (Control of Documents), and 4.2.5, (Control of Records) preferred.
• Ability to problem-solve, often cross-functionally and with various departments and levels of employees.
• Computer application skills, e.g., Microsoft Office, Word, Excel, Outlook.
• Ability to read and interpret engineering drawings

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, Los Angeles County Fair Chance Ordinance, and San Francisco Fair Chance Ordinance.