Kelly Services Quality Assurance, Document Control in Sunnyvale, California
Title: Document Control Administrator
This position plays a central role in the Quality Assurance Department by creating, tracking, and maintaining technical documentation for Quality and Operations functions. This position will ensure records are organized, indexed, and maintained in a centralized location to ensure ready access as needed to contribute to the overall consistent quality of our products. This position supports the implementation of the company s quality systems in compliance with cGMPs and other company policies.
Develop/revise and maintain templates for controlled documents such as SOPs, forms, batch records, specifications, reports, etc.
Interact with all departments to develop and implement functional documents in support of appropriate clinical phase readiness.
Provide Document Control support including, but not limited to, processing requests for and distributing controlled documents, logbooks, and quality events.
Ensure the timely release of documents needed for manufacturing and testing processes.
Maintain and improve the existing quality events management program and transition to an electronic system when software is implemented.
Maintain and improve the existing paper-based training program and transition to a semi-electronic system when training software is implemented.
Revise and maintain procedures and practices for archiving and retention of completed controlled documentation and records.
Maintain an index of archived materials and oversee the movement of records to offsite storage.
Provide training to staff on both paper-based and electronic document control and quality events systems.
Work with all departments supporting GMP activities to establish and implement departmental documentation needs.
Develop and maintain documentation systems in terms of applicable regulations and industry practices.
Serve as the subject matter expert for documentation systems during client and regulatory agency audits.
Assist in the maintenance of regulatory documents as necessary.
Why Kelly ® ?
With Kelly, you’ll have access to some of the world’s highest regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.
About Kelly ®
At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm