Change Analyst position available with a global leader in the production of Medical Devices in Raynham, MA
- Accountable for the 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 Orders 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 personal growth.
- Be an extremely flexible team player, adaptable to change.
- Be customer service oriented and experienced in interacting with individuals at all levels, including upper management.
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.
Benefits and Perks: You’ll enjoy competitive pay as well as a comprehensive array of benefits for which you may be eligible, including:
- Health Insurance
- Dental Insurance
- Vision Insurance
- 401 (k)
- Paid Time Off
- Paid Holidays
- Online Training via the Kelly Learning Center
Kelly puts you in charge of your career, with access to cutting edge projects and technologies in industry leading organizations. Top companies throughout the world have trusted Kelly as a premier source of engineering talent and services since 1965. And engineering job seekers know Kelly as a firm with an unmatched reputation for quality, integrity and professionalism. Whether you seek the variety and flexibility of working on short term project engagements, or prefer contract-to-hire or direct hire placement with our clients, apply with Kelly to explore opportunities that suit your specific professional interests.
About Kelly Services®
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 2017 was $5.4 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.
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