Job Description

When you’re part of the team at Thermo Fisher Scientific, you’ll do meaningful work, that makes a positive impact on a global scale! Join 80,000 colleagues who bring our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. You’ll find the resources here to achieve your career goals and help take science a step beyond by developing solutions for some of the world’s toughest challenges. This includes protecting the environment, making sure our food is safe, and helping find cures for cancer.”

Location/Division Specific Information

BioProduction Group (BPG) - Detroit, MI Peptone Manufacturing Site.

How will you make an impact?

You will provide Quality Assurance Support to a life science manufacturing facility in Detroit, MI. You will make an impact by conducting root cause analysis (RCAs) and implementing corrective/preventative (CAPAs) actions and drive quality goals and objectives.

What will you do?          

• Investigate process/product deviations by applying various root cause analysis (RCA) methods and tools such as Cause and Effect Diagrams, 5-Whys…etc.
• Implement corrective and preventative actions (CAPAs) to prevent recurrence of deviations and nonconformances. 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 complex improvement projects following risk-based methodologies.
• Have strong knowledge of Quality tools such as FMEA, risk analysis, validation principles, 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.
• Drives for continuous improvements in all areas and support improvements efforts, implement changes, and verifies effectiveness of changes.
• Write or revise standard quality control operating procedure and quality system documentation as required.
• Write technical reports such investigation summary reports.

Education:

Minimum: Bachelor of Science (BS) Degree in a scientific. Engineering Degree is preferred.

Experience:

• A minimum of 3 - 6 years prior experience in a Quality Engineering position in a cGMP Pharmaceutical/Biotech/or Life Science site. Alternative Quality experience may be accepted.  

• Proven ability to conduct quality investigations by using various investigational tools.
• Prior experience with the release and disposition of nonconforming product through the application of risk assessment and root cause analysis tools.
• 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.
• 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 Power Point) is a must. Knowledge of a statistics data software (Minitab, JMP…etc) is highly desirable.

At Thermo Fisher 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 EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.