Failure Investigation Specialist

4 weeks ago


Solna Municipality, Sweden Cepheid Full time
Job Description

Cepheid is a leading molecular diagnostics company dedicated to improving healthcare through the development, manufacturing, and marketing of accurate and easy-to-use molecular systems and tests.

The Failure Investigation team, part of the Technical Operations department, consists of 35 professionals responsible for investigating quality issues in manufacturing and solving problems related to product performance.

The Failure Investigation Analyst will support ongoing production with laboratory testing to understand failure modes and drive to root cause analysis. This role 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. The analyst may also support other departments and participate in Test Method Validations (TMV) or other validation activities.

We are currently seeking a Failure Investigation Analyst to work day-and-evening shifts, Monday through 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 achieving departmental goals.
  • 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 one year of relevant professional experience.

The ideal candidate will have hands-on laboratory experience, documentation skills, and the ability to work independently and cross-functionally. Strong organizational and communication skills are essential, as is flexibility and teamwork. A service-minded attitude and collaboration skills are also necessary to support colleagues with knowledge and expertise.

Cepheid values diversity and the existence of similarities and differences in our workforce, workplace, and markets. Our associates, customers, and shareholders contribute unique perspectives due to these diverse attributes.



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