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Failure Investigation Analyst

2 months ago

Solna, Sweden Cepheid Full time

Cepheid is a leading molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. In our facilities in Solna / Sundbyberg we develop and manufacture diagnostics tests that improve patient outcome all over the world.

The Failure Investigation team belongs to the department of Technical Operations and consists of 35 people. The team is responsible for investigation of quality issues in manufacturing and solving problems related to product performance. The Failure Investigation Analyst is supporting ongoing production with laboratory testing to understand failure modes and drive to root. The person taking 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 of laboratory testing, execution of experiments and result reporting to other team members. FI Analyst can also support other departments and participate in Test method validations (TMV) or other validation activities. Root cause analysis and solving problems is the heart of our area and if you are interested in working in a highly dynamic and fast pace environment where work tasks and focus is changing from day to day this is the place for you

We are currently looking for a Failure Investigation Analyst who can work day-and evening shifts Monday-Friday.

Responsibilities and tasks:

Performing of testing for various Cepheid products to help driving 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

Perform non-routine testing according to experimental plan

Assist in keeping trending files updated

Actively contribute to achievements of goals in the department

Support and assist in various improvement activities

To succeed in the best possible way in this role we believe that you have:

B.S in Life Sciences, BMA or related degree or equivalent combination of education and experience to perform at this level

Minimum of 1 year’s relevant professional experience

We also think it is necessary to have:

Experience of hands on laboratory activities and documentation of results

Ability to work independently and cross-functionally to provide effective support

Ability to successfully handle multiple testing activities simultaneously within short deadlines

Good organizational and communication skills

Attitude of flexibility as well as good teamwork

Service minded attitude and good collaboration skills to support with knowledge and expertise

Selection of candidates and interviews are ongoing and the position may be filled before application deadline, so please don't hesitate to submit your application so we can get to know you

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