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:
- Change Control Management: Oversee the change control system by reviewing, routing, assessing training impacts, and releasing change orders.
- Training Support: Assist in training related to the change control system software and other necessary areas.
- Project Coordination: Ensure timely and accurate completion of projects, interacting effectively with internal and external customers.
- Audit Support: Assist Quality teams during external and internal audits.
- Document Monitoring: Track in-process document changes to ensure timely revisions.
- Customer Assistance: Provide support to internal customers regarding document control processes.
- Standards Maintenance: Maintain external standards following standard operating procedures.
- Software Improvement: Support testing and enhancement of change control and other supporting software.
Required Skills:
- Experience: Minimum of 2+ years in a related field or equivalent combination of education and experience.
- Technical Proficiency: Skilled in Microsoft Office Suite and knowledgeable in electronic documentation systems.
- Document Control Knowledge: Understanding of Document Control requirements and processes as outlined in ISO 13485 and 21 CFR Part 820.
Preferred Skills:
- Regulatory Knowledge: Ability to apply Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP) to daily tasks.
- Critical Thinking: Strong problem-solving abilities to resolve issues effectively.
Education Requirements:
- High school diploma or GED required.
Software Skills Required:
- Experience with Cloud PLM Document Control systems or equivalent.
Additional Information:
- 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.