Document Control Specialist I

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 Client priorities of Corporate 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 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.   PROFESSIONAL EXPERIENCE REQUIREMENTS: • 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. EDUCATIONAL REQUIREMENTS: • A minimum of a Bachelor Degree is required. All your information will be kept confidential according to EEO guidelines.