Document Specialist I

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

eTeam was formed in 1999 with the goal of becoming the supplier of choice for clients, employees and contingent workers. Today, we’re one of the fastest-growing companies in New Jersey and ranked as one of the best companies to work for by Staffing Industry Analysts and New Jersey Business. We’re also an honored member of Deloitte’s Technology Fast 50

Job Description

Accountable for administration of the Change Order (CO) process. Accountable for compliance with the Food and Drug Administration’s (FDA) Quality System Regulation (QSR) as it pertains to Documentation and Documentation Control. Accountable for the timely processing and release of new and changed controlled documents.

Position Duties & Responsibilities

• Accountable that all Change Order (CO) are reviewed for completeness, accuracy and compliance with applicable policies and procedures.
• Coordinate workflow and Client Synthes priorities of Document Control West Chester with management and Change Owners on an as needed basis.
• Communicate CO status information as requested.
• Administer the Periodic Review process for controlled Quality documents.
• Manage Designated Alternate Signature forms.
• Proactively seek methods of increasing efficiency while maintaining compliance in all areas of responsibility on a continuing basis.
• Provide historical and current documentation in response to queries from management and other departments as needed.
• Exhibit excellent organizational and communication skills.
• Properly employ all Synthes SOPs, Work Instructions, Training Guides, and Forms in the performance of tasks.
• Maintain a work environment that provides open communication and personnel growth.
• Be an extremely flexible team player, adaptable to change.
• Be customer service oriented and experienced at interacting with individuals at all levels, including upper management.
• Perform other special projects and support functions as assigned by the Manager of Document Management.
• Required to know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
• Diligently participate in our compliance program‑related activities as denoted by supervisor or our Chief Compliance Officer.

Qualifications

• A minimum of a Bachelor Degree is required.
• A minimum one year (professional, intern or co‑op) in a GMP and/or ISO regulated environment is required.
• Familiarity with various PC‑Based viewing systems (WebView, Product View, Agile, etc.) is required.
• Proficient with Microsoft Office products (Word, Excel, Power Point, etc.) is required.
• Previous document control experience is preferred.
• Medical device, Pharmaceutical and/or Biotech experience is preferred.
• Proficient with various PC‑Based CAD systems (Pro/Engineer, Windchill, Medusa, AutoCAD, etc.) is preferred.