Thermo Fisher Scientific Quality Engineer II in Detroit, Michigan
When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.
Location/Division Specific Information
Life Sciences Group (LSG) - BioProduction Division. Detroit, MI Peptone Manufacturing Site.
How will you make an impact?
As an Engineer II, QA, you will have the opportunity to support a life science manufacturing facility acting as a Quality Engineering subject matter expert. You will make an impact by conducting root cause analysis (RCAs) and implementing timely corrective/preventative (CAPAs) actions to reach effective problem resolutions. You will also provide quality leadership to maintain the health of the Quality Investigation System.
What will you do?
Investigate process/product deviations and out of specification conditions utilizing various root cause analysis (RCA) methodologies and tools such as Cause and Effect Diagrams, 5-Whys... etc.
Implement corrective and preventative actions (CAPAs) to prevent recurrence of deviations and nonconformances and verify effectiveness of implemented changes.
Provide guidance for the disposition of non-conforming material (final product and raw material).
Perform statistical analysis to monitor process and product performance and react to negative trends.
Lead change controls for improvement projects utilizing risk-based methodologies.
Proficient in using various Quality tools such as FMEAs, risk analysis, validation principles, statistical sampling plans, Six Sigma and control plans.
Lead and participate in generating risk assessments (product and process - FMEAs).
Have strong knowledge of process, product and equipment validation principles (i.e IQ/OQ/PQ..etc) following GAMP principles and cGMP requirements. This includes generating protocols and reports, creating acceptance criteria, establishing proper sampling plans and completing statistical analysis.
Maintain the site's Quality Systems' conformance to ISO standards and regulatory requirements and policies.
Drives for continuous improvements in all areas and support all quality improvement efforts.
Support internal and customer/external audits.
Perform Quality Assurance (QA) responsibilities as needed to support manufacturing activities and material release.
Write or revise standard quality control operating procedure and quality system documentation as required.
Write technical reports such investigation summary reports and change management records.
How will you get here?
Bachelor of Science (BS) Degree in a scientific/Engineering discipline required. Graduate degree (MS) a plus. High school diploma/GED is a minimum educational requirement.
A minimum of 2 years prior experience in a Quality Engineering role in a cGMP Pharmaceutical/Biotech/or Life Science site.
Demonstrated ability to conduct quality investigations including root cause analysis and determining corrective / preventative actions.
Prior experience with the release and disposition of nonconforming product through the application of risk assessment and root cause analysis tools.
Prior experience with an electronic Quality Management system software utilized for product investigations and dispositions.
Demonstrated validation proficiency, with knowledge of product, process and equipment qualifications and validations (IQ/OQ/PQ).
Good data analysis skills, with an ability to use statistical methods to conduct quality investigations.
Strong knowledge of ISO 13485 standards and FDA cGMP regulations (i.e 21 CFR 820).
Lean Sigma Green or Black Belt certified a plus.
ASQ CQE a plus.
Knowledge, Skills, Abilities
Excellent verbal and written communication skills and ability to collaborate across different levels of the organization.
Knowledge of cGMP regulations and ISO standards.
Excellent organization skills with strong attention to details.
Ability to multitask efficiently to support production demand.
Computer skills: knowledge of Microsoft Office applications (Work, Excel and PowerPoint) is a must.
Knowledge of a statistics data software (Minitab, JMP... etc) is highly desirable.
At ThermoFisher Scientific, each one of our 70,000 plus extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.
Apply today! http://jobs.thermofisher.com
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
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