Documentation Specialist
Documentation Specialist Kelly Services is currently seeking a Doc Specialist/ Change Analyst for one of our top clients in Raynham, MA. As a Change Analyst placed with KellyOCG you will be responsible for the following:
- 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 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.
EDUCATION EXPERIENCE REQUIREMENTS:
- Bachelor Degree is preferred, but not 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.
- Windchill experience is desirable.
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