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 in person 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 perks 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 For more information visit

📌 Quality Systems Document Control Change Analyst Iii (Bengaluru)
🏢 Danaher
📍 Bengaluru