Quality Systems Document Control Lead

At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world's most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.

Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we're working at the pace of change on diagnostic tools that address the world's biggest health challenges, driven by knowing that behind every test there is a patient waiting.

Learn about the Danaher Business System which makes everything possible.

The Quality Systems Document Control Lead assists the Document Control Manager in leading the change control process in compliance with applicable regulatory requirements. The Document Control Lead will assist in overseeing document and record control operations, policies, and procedures the secure management and access of Cepheid controlled documents and records. The position will report directly to the Document Control Manager.

This position is part of the Quality System and will be HYBRID and located in Sunnyvale, CA. This requires 3 days onsite. At Cepheid, our vision is to be the leading provider of seamlessly connected diagnostic solutions.

In this role, you will have the opportunity to:

• Be the subject matter authority on all current change control workflows and processes. Provide timely responses, solutions, and answers to a wide variety of requests related to document control and change process activities received within an electronic work ticket system and via email and telephone from a rapidly growing and diverse group of associates employed locally and worldwide.

• Assist the Document Control supervisor or manager with task scheduling, work assignments, and other workload balancing activities.

• Mentor Document Control Change Analysts to address daily quality audits of change orders processed to evaluate the accuracy and conformance to required procedures and performance improvement projects and initiatives. Support Change Analyst on processing daily Change Orders.

The essential requirements of the job include:

• High School degree (or equivalent experience) with 6+ years of related work experience OR AA or Technical Trade Degree with 5+ years of related work experience.

• 1 year experience in leading teams or projects.

• Confirmed understanding of Quality System Regulations (21 CFR Part 820, FDA cGMP) and ISO requirements (13485-2016).

• Experience in compiling data to support metrics reporting and analyzing current processes.

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

• Excellent verbal and written communication skills in group or one-on-one settings.

• Thorough familiarity with at least one PLM System (Oracle/Agile or Oracle Cloud preferred).

• Computer skills:

• Microsoft Office Suite (Word, Excel, Powerpoint) at minimum intermediate level.

• Experience editing and converting files to Adobe Acrobat .pdf format.

• Understanding of SharePoint, remote conferencing applications, etc.

The hourly range for this role is $35 - $48. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range. This range may be modified in the future. This job is also eligible for bonus/incentive pay.

We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.

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At Danaher we bring together science, technology and operational capabilities to 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. Our global teams are pioneering what's next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

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We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation.