Quality Systems Document Control Change Analyst III

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

At Cepheid, one of 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 which makes everything possible.

The Quality Systems Document Control Change Analyst III ensures compliance with corporate quality standards, QSR, ISO, and global regulations by reviewing change orders and managing controlled document lifecycles. The role supports Agile administration, including part number and manufacturer updates, user training backup, UAT activities, PLM projects, and access management. Additional responsibilities include verifying documentation accuracy, maintaining audit-ready records, providing user support via phone, Spirit tickets, Teams, and walk-ins, and generating weekly and monthly metrics for change orders and Spirit tickets to track performance indicators.

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 AWF and UAWF workflows with support for SAWF, REF, NCC, DCO, VWF, and SWCO, ensuring compliance with corporate quality standards, regulatory requirements, and cGMP while verifying document accuracy and completeness prior to approval routing
• Perform Agile PLM administration by creating and modifying part numbers and manufacturer records, supporting UAT activities and special PLM projects, managing Agile access and account deactivation, and responding to Spirit tickets, Teams messages, phone coverage, and inperson system inquiries
• Maintain documentation accuracy and workflow alignment by incorporating approved revisions, preparing files for release per QSR, ISO, and internal procedures, and generating weekly and monthly reporting metrics for Agile Change Orders and Spirit tickets to track document control performance indicators

The essential requirements of the job include

• Experienced in compiling data to support metrics reporting and analyzing processes for continuous improvement
• Education & Experience: High School diploma (or equivalent) with 4-6 years of related experience, or Associate/Technical Trade degree with 2-4 years of 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.

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 .

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.

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