Product Stability Analyst

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.
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The Product Stability Analyst is responsible for providing support throughout the life cycle of GX assay products and to perform stability studies in accordance to FDA and ISO regulations. The Stability Analyst is expected to independently plan and perform stability studies, test method validations, and perform tasks and activities related to the laboratory. Other responsibilities include initiate and perform laboratory failure investigations, analyze results, and update stability reports. Interaction with departments such as R&D, Quality Control, Failure Investigation and Quality Assurance is expected. The group provides opportunities to learn statistical analysis for process control, process capability, and design of experiments (e.g. Minitab and RStudio) and to participate in improvement projects with cross-functional interactions.
This position is part of the Product Life Cycle Quality Assurance department and will be located in Solna. At Cepheid, our vision is to be the leading provider of seamlessly connected diagnostic solutions.


In this role, you will have the opportunity to:

· Plan and perform stability studies. Generate/present data summaries, trending, and update stability reports.
· Plan and perform test method validations, other validation testing and non-routine testing.
· Revise and update product testing procedures and worksheets as appropriate to correct and/or optimize testing processes.
· Initiate, report and investigate laboratory failure investigations (LFIs).
· Interact and obtain expertise from other departments to aid in investigation activities.
· Participate in investigations with laboratory assistance.
· Perform lab duties as assigned or requested.


The essential requirements of the job include:

· Bachelor's/Master's degree in Life Sciences or equivalent experience
· 0-2 years of work experience in Life Sciences
· Laboratory experience including cGMP documentation practices


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

· Proficiency in Molecular Biology Techniques and preferably experience from real time PCR
· Computer skills including the office package
· Good written and verbal communication skills in English
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 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.


At Danaher, 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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