Document Control Specialist I – GMP/ISO Compliance

eTeam; West Chester (Chester County); On-site; USD 50,000 - 70,000; Full time

Job summary

A leading staffing firm located in Chester County, West Chester in the United States, is seeking talent to manage the Change Order process while ensuring compliance with FDA regulations. The ideal candidate should hold a Bachelor's Degree and have at least one year of experience in a GMP and/or ISO environment. Proficiency in Microsoft Office and familiarity with document control processes are crucial for success in this role. This position offers opportunities for professional growth and development while maintaining communication and teamwork at its core.

Qualifications

• Minimum of a Bachelor's Degree required.
• At least one year in a GMP and/or ISO regulated environment.
• Familiar with various PC-Based viewing systems.
• Proficient in Microsoft Office products.
• Document control experience preferred.
• Experience in Medical device, Pharmaceutical, or Biotech preferred.

Responsibilities

• Administer the Change Order (CO) process compliance.
• Coordinate workflow with management and Change Owners.
• Manage controlled Quality documents.
• Improve efficiency while maintaining compliance.
• Communicate CO status information as needed.

Skills

Organizational skills

Communication skills

Customer service orientation

Education

Bachelor's Degree

Tools

Microsoft Office (Word, Excel, Power Point)

PC-Based viewing systems (WebView, Product View, Agile)

CAD systems (Pro/Engineer, Windchill, AutoCAD)

Job description

A leading staffing firm located in Chester County, West Chester in the United States, is seeking talent to manage the Change Order process while ensuring compliance with FDA regulations. The ideal candidate should hold a Bachelor's Degree and have at least one year of experience in a GMP and/or ISO environment. Proficiency in Microsoft Office and familiarity with document control processes are crucial for success in this role. This position offers opportunities for professional growth and development while maintaining communication and teamwork at its core.