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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.
In this role, you will have the opportunity to:
- Responsible for prioritization of daily QA activities to ensure batch record and document releases are met.
- Train and supervise QA personnel and cross functional team on general quality principles and specific procedural requirements to support QA release activities.
- Positive interaction with internal Associates to identify and address deficiencies quickly and effectively to ensure completion of follow-up actions, specifically those that target process fixes and to maintain consistent resolution to all batch review issues according to GMP, QSR and ISO requirements.
- Develop and maintain QA metrics such as Daily Management KPI and release metrics to track batch record and document review capabilities and workflow to report regularly to management.
- Generate or update written standard operating procedures to define and improve Quality System function.
- Provide companywide training on general quality principles and specific procedural requirements.
- Support Non-conforming (NC) process, Deviation, Quality Audits and other systems that support Quality System.
The essential requirements of the job include:
- Bachelor's degree in scientific, quality system, or related discipline, with minimum 5 years of Quality experience in a regulated manufacturing environment OR Master's degree in scientific, quality system, or related discipline, with minimum 3 years of Quality experience in a regulated manufacturing environment.
- 2+ years of experience in Supervising role.
- Ability to work 7 AM to 3 PM Tuesday through Saturday
- Ability to perform routine statistical applications and ability to transfer those skills to others.
- Experience in Problem-Solving Process to solve complex problem.
- Experience in the medical device industry, knowledge of CFR 21 Part 820(QSR), ISO13485.
- Experience in NC process, Deviation Report, OOS and quality audits that support the Quality System.
It would be a plus if you also possess previous experience in:
- Experience in DNA diagnostics and other medical devices.
Cepheid, a Danaher 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 danaherbenefitsinfo.com.
When you join us, you'll also be joining Danaher's global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you'll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.
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.
The EEO posters are available here.
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.
If you've ever wondered what's within you, there's no better time to find out.
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