Document Control Specialist

Manpower; San Diego (CA); On-site; USD 48,216 - 55,104; Full time

Job summary

A dynamic organization is seeking a meticulous Document Control Specialist to manage change control systems and ensure compliance with industry standards. This role involves overseeing change orders, supporting training, and assisting during audits, making it essential for maintaining quality in the medical equipment manufacturing sector. If you have a passion for document control and compliance, this is a fantastic opportunity to contribute to a vital industry while enhancing your skills in a supportive environment. Join a team where your attention to detail will be valued and rewarded!

Qualifications

• Minimum of 2+ years in a related field or equivalent combination of education and experience.
• Understanding of Document Control requirements as per ISO 13485 and 21 CFR Part 820.

Responsibilities

• Oversee the change control system and manage document revisions.
• Assist in training and provide support to internal customers.

Skills

Document Control Knowledge

Technical Proficiency in Microsoft Office Suite

Critical Thinking

Experience in Change Control Management

Education

High school diploma or GED

Tools

Cloud PLM Document Control systems

Job description

This range is provided by Manpower. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$35.00/hr - $40.00/hr

Company Overview: We are a dynamic organization seeking a meticulous and experienced Document Control Specialist to join our team. This role is pivotal in managing our change control system and ensuring compliance with industry standards.

Key Responsibilities:

1. Change Control Management: Oversee the change control system by reviewing, routing, assessing training impacts, and releasing change orders.
2. Training Support: Assist in training related to the change control system software and other necessary areas.
3. Project Coordination: Ensure timely and accurate completion of projects, interacting effectively with internal and external customers.
4. Audit Support: Assist Quality teams during external and internal audits.
5. Document Monitoring: Track in-process document changes to ensure timely revisions.
6. Customer Assistance: Provide support to internal customers regarding document control processes.
7. Standards Maintenance: Maintain external standards following standard operating procedures.
8. Software Improvement: Support testing and enhancement of change control and other supporting software.

Required Skills:

1. Experience: Minimum of 2+ years in a related field or equivalent combination of education and experience.
2. Technical Proficiency: Skilled in Microsoft Office Suite and knowledgeable in electronic documentation systems.
3. Document Control Knowledge: Understanding of Document Control requirements and processes as outlined in ISO 13485 and 21 CFR Part 820.

Preferred Skills:

1. Regulatory Knowledge: Ability to apply Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP) to daily tasks.
2. Critical Thinking: Strong problem-solving abilities to resolve issues effectively.

Education Requirements:

1. High school diploma or GED required.

Software Skills Required:

1. Experience with Cloud PLM Document Control systems or equivalent.

Additional Information:

1. Potential for assignment extension or conversion to full-time employment based on performance and business needs.

If you are a detail-oriented professional with a passion for document control and compliance, we encourage you to apply for this opportunity.

Seniority level

Mid-Senior level

Employment type

Temporary

Job function

Quality Assurance

Industries

Medical Equipment Manufacturing