Quality Systems Document Control Change Analyst II

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Cepheid, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. 

You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.

At Cepheid, we are passionate about improving health care through fast, accurate, molecular diagnostic systems and tests. As a member of our team, you’ll get to make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Our mission drives us to develop groundbreaking solutions for the world’s most complex health challenges. Together, we bring MORE change to the world.

Learn about the Danaher Business System which makes everything possible.

The Quality Systems Document Control Change Analyst II ensures organizational compliance and operational excellence by reviewing Change Orders and managing controlled document lifecycles to meet corporate quality standards and global regulatory requirements. Drive efficiency and collaboration across the enterprise by delivering timely document control solutions, maintaining accurate records, and continuously improving processes through SOP updates and best practices.

This position reports to the Document Control Manager and is part of Quality Systems located in Sunnyvale and will be a hybrid role to cover India.

In this role, you will have the opportunity to:

• Review and validate Change Orders within Reference Document Change Order (REF), Non-Content Change (NCC), Design Change Order (DCO), Validation Workflow (VWF), and Software Change Order Workflow (SWCO) workflows for compliance with corporate quality standards, regulatory requirements, and cGMP; verify document accuracy and completeness before routing for approval.
• Ensure documentation accuracy and workflow alignment by verifying completeness, incorporating approved revisions, and preparing files for release in accordance with QSR, ISO, and internal procedures; maintain compliance and audit-ready records.
•  Manage document control and provide support by overseeing manual systems (issuance, filing, archiving, SOP updates) and responding to change process requests via Work Ticket system, email, and phone for global associates.

The essential requirements of the job include:

• Education & Experience: High School Diploma (or equivalent) with 2–4 years related experience, OR Associate/Technical Trade Degree with 1–2 years related experience.
• Technical Skills: Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), ability to edit/convert files to Adobe Acrobat (.pdf), and familiarity with SharePoint and remote conferencing tools.
• Communication & Interpersonal Skills: Excellent verbal and written communication; ability to work effectively with diverse teams and guide group dynamics

It would be a plus if you also possess previous experience in:

• Understanding of Quality System Regulations (21 CFR Part 820, FDA cGMP) and ISO requirements 13485
• Familiarity with PLM systems, ideally Oracle Agile

Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.