Document Specialist

Document Specialist I

Change Analyst – West Chester, PA

OVERALL RESPONSIBILITIES:

• 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’s (CO) are reviewed for completeness, accuracy and compliance with applicable policies and procedures.

• Coordinate workflow and Company priorities of Document Control 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 Company 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.

EDUCATION & EXPERIENCE REQUIREMENTS:

• A minimum of a Bachelor Degree is preferred.

• 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.

Job Type: Contract

Salary: $26.30 /hour