Failure Investigation Expert
4 weeks ago
Cepheid is a leading molecular diagnostics company focused on developing and manufacturing accurate and user-friendly molecular systems and tests. Our facility in Solna Sundbyberg is dedicated to developing and manufacturing diagnostic tests that improve patient outcomes worldwide. The Failure Investigation team is part of the Technical Operations department and consists of 35 members, responsible for investigating quality issues in manufacturing and resolving problems related to product performance. The team requires a Failure Investigation Analyst to support ongoing production with laboratory testing to understand failure modes and identify the root cause. The analyst will work in accordance with cGMP standards for documentation, data compilation, and batch record review to justify product release. Key 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.
Responsibilities:
- Perform testing for various Cepheid products to drive root cause analyses for Non-Confirming lots.
- Support customer complaint investigations with testing.
- Perform TMV or other validation testing as needed and summarize the results.
- Conduct non-routine testing according to experimental plans.
- Assist in maintaining up-to-date trending files.
- Contribute to achieving departmental goals.
- Support and assist in various improvement activities.
Requirements:
- Bachelor’s degree in Life Sciences, BMA, or a related field, or an equivalent combination of education and experience.
- Minimum one year of relevant professional experience.
Desirable qualifications:
- Experience with hands-on laboratory activities and documentation of results.
- Ability to work independently and cross-functionally to provide effective support.
- Ability to manage multiple testing activities simultaneously within tight deadlines.
- Good organizational and communication skills.
- Flexible attitude and good teamwork.
- Service-minded attitude and good collaboration skills to support with knowledge and expertise.
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