Change Analyst

Position Duties

• 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.
• Ensure all Change Order(s) CO are reviewed for completeness, accuracy, and compliance with applicable policies and procedures.
• Cook up 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.

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.

Education

Preferred: Bachelor Degree.

Required: One year professional, intern or co-op in a GMP and/or ISO regulated environment.

Desirable: Windchill experience.

Important Information

This position is recruited by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States.

About Kelly Services

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce.

Why Kelly® Engineering?

Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world’s most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth.

Equal Employment Opportunity

Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. Kelly may use AI-powered tools during the recruitment and hiring process.