Failure Investigation Specialist
4 weeks ago
Cepheid is a leading molecular diagnostics company dedicated to improving healthcare by developing, manufacturing, and marketing accurate molecular systems and tests. Our team in Solna/Sundbyberg develops and manufactures diagnostic tests that improve patient outcomes worldwide.
The Failure Investigation team, part of Technical Operations, consists of 35 people responsible for investigating quality issues in manufacturing and solving problems related to product performance. As a Failure Investigation Analyst, you will support ongoing production with laboratory testing to understand failure modes and drive to root cause. You will work in accordance with cGMP standards for documentation, data compilation, and batch record review to justify product release.
Daily responsibilities include planning laboratory testing, executing experiments, and reporting results to team members. You may also support other departments and participate in Test Method Validations (TMV) or other validation activities. Root cause analysis and problem-solving are core aspects of our area, and if you're interested in working in a dynamic and fast-paced environment with changing tasks and focus, this is the place for you.
We're currently seeking a Failure Investigation Analyst to work day-and-evening shifts, Monday to Friday.
Key Responsibilities:
- Perform testing for various Cepheid products to aid in root cause analyses for Non-Confirming lots.
- Support customer complaint investigations with testing.
- Perform TMV or other validation testing as needed and summarize results.
- Conduct non-routine testing according to experimental plans.
- Assist in maintaining trending files.
- Contribute to departmental goal achievements.
- Support and assist in various improvement activities.
Requirements:
- Bachelor's degree in Life Sciences, BMA, or related field, or equivalent combination of education and experience.
- Minimum 1 year of relevant professional experience.
Desirable Skills:
- Hands-on laboratory experience and documentation of results.
- Ability to work independently and cross-functionally to provide effective support.
- Capacity to handle multiple testing activities simultaneously within tight deadlines.
- Good organizational and communication skills.
- Flexibility and teamwork attitude.
- Service-minded attitude and collaboration skills to support with knowledge and expertise.
Selection and interviews are ongoing, and the position may be filled before the application deadline. Please submit your application to get to know you better. If you have any questions, contact Katarina Kelava (Katarina.Kelava@cepheid.se).
Cepheid partners with customers worldwide to help them solve complex challenges, architecting solutions that bring the power of science to life.
At Cepheid, we value diversity and the existence of similarities and differences found in our workforce, workplace, and markets we serve. Our associates, customers, and shareholders contribute unique and different perspectives as a result of these diverse attributes.
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