Document Specialist I

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 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.

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.

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