Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
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 to drive quality goals and objectives. You will make an impact by conducting root cause analysis (RCAs) and implementing corrective/preventative (CAPAs) actions and applying validation principles.
What will you do?
- Use (RCA) methods and tools to investigate process/product deviations and out of specification conditions.
- Implement effective corrective and preventative actions (CAPAs) to eliminate recurrence of deviations and nonconformances.
- Disposition non-conforming material (final product and raw material).
- Write technical reports such investigation summary reports.
- Perform statistical analysis to improve process and product performance.
- Lead and generate risk assessments (product and process- FMEAs).
- Perform process, product and equipment validations (i.e IQ/OQ/PQ..etc) in alignment with GMP requirements including protocol and report generation, acceptance criteria and statistical sampling plans. Conduct validation failure investigations.
- Drive continuous improvements in all areas and support improvements efforts.
- Perform Quality Assurance (QA) responsibilities to support manufacturing activities including support to site's QMS.
Education:
Minimum: Bachelor of Science (BS) in a scientific field
Experience:
- A minimum of 5 years prior experience in Quality Engineering including validation in a pharmaceutical or Life Science position. Equivalent Quality experience can be evaluated.
- Experience in conducting quality investigations and establishing corrective / preventative actions.
- Knowledge of Quality tools such as FMEA, risk analysis methods, validation, sampling plans, Six Sigma and use of statistical methods.
- Applied risk assessment tools and methods to disposition nonconforming product.
- Experience with ISO 13485 standards and FDA cGMP regulations (i.e 21 CFR 820).
Knowledge, Skills, Abilities
- Excellent verbal and written communication skills and ability to collaborate across different levels of the organization.
- Excellent organization skills with strong attention to details.
- Ability to multitask efficiently to support production demand.
- Technical proficiency: familiarity with Microsoft Office applications (Word, Excel, and PowerPoint) is required. Proficiency in a statistics data software (Minitab, JMP…etc).
- Lean Sigma Green or Black Belt or ASQ CQE a plus.
At Thermo Fisher Scientific, each one of our 70,000 plus extraordinary minds has a unique story to tell. Join us and support our singular mission—enabling our customers to make the world healthier, cleaner and safer.
Apply today! http://jobs.thermofisher.com