Engineer/Scientist III, QC

3 weeks ago

Fremont, United States Thermo Fisher Scientific Full time

This position will perform various laboratory operation tasks such as; sample receipt, data generation, product verification, data analysis and summarization, out-of-specification investigations, raw material qualifications, and other QC lab supporting activities. Using standard operating procedures (SOP) and good manufacturing practices (GMP), the will perform routine and non-routine testing of incoming and manufactured raw materials. Regularly provides mentorship and training to junior QC Engineer/Scientists.

What will you do?

Conduct analytical and functional testing of raw materials according to approved SOPs.  Act independently to determine methods and procedures when performing new assignments. Perform testing using chemistry clinical analyzers and document accurate test results using spreadsheets and workbooks. Review and interpret data against trend charts, in order to evaluate product performance. Perform initial solving of issues which arise during routine analysis, and perform out of specification investigations. If needed, initiate non-conformance reports, CAPAs, deviations or variances. Lead improvements projects within area, and participate in PPI and 5S programs to drive continuous improvements. Work multi-functionally to resolve product issues, maintain timelines, and ensure product quality. Review and approve documentation completed by other QC Engineer/Scientists. Perform revisions and updates to SOPs and initiate document change orders.  Participate in interdepartmental and team meetings to support new product development, validations, and sustaining projects.  Perform other responsibilities to support the needs of the department as assigned by the Supervisor. 

How will you get there?

Education

Minimum BS/BA in Chemistry, Biochemistry, Bioscience or related degree

Experience

5+ years of Assurance/Quality Control experience, preferably in the medical diagnostics industry

Knowledge, Skills, and Abilities

Strong laboratory skills including pipetting, safety, and hazardous chemical handling.  Effective leadership skills to informally lead teams, and influence others. Understanding of cGMP and how it applies to the work environment. Ability to write clear, understandable documentation. Ability to follow written and verbal directions with a high level of accuracy.  Strong verbal communication skills.  Intermediate word processing and spreadsheet software skills.  Ability to manage multiple tasks simultaneously.  Ability to work independently. Ability to perform data analysis, interpret and summarize results.  Basic math skills including calculation of concentrations and dilutions and a strong grasp of algebraic concepts.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one global team of 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation

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