Change Order Analyst, West Chester, PA
14-Week Contract via Kelly Services
- 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 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.
Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States.
- As a Kelly Services employee, you will have access to numerous perks, including:
- Exposure to a variety of career opportunities as a result of our expansive network of client companies
- Career guides, information and tools to help you successfully position yourself throughout every stage of your career
- Access to more than 3,000 online training courses through our Kelly Learning Center
- Weekly pay and service bonus plans
- Group-rate insurance options available immediately upon hire*
At Kelly Services®, we work with the best. Our clients include 95 of the Fortune 100™ companies, and more than 70,000 hiring managers rely on Kelly annually to access the best talent to drive their business forward. If you only make one career connection today, connect with Kelly.
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2016 was $5.3 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.
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. Equal Employment Opportunity is The Law.