Engineer III, QA

at  Thermo Fisher Scientific

KNOWLEDGE/EDUCATION/EXPERIENCE REQUIRED:

• Minimum Level of Education: Bachelor’s Degree in Chemistry or Analytical Chemistry, or equivalent experience. Preferred Level of Education: Master’s Degree in Chemistry or Analytical Chemistry, or equivalent experience.
• Job-related experience within the pharmaceutical industry.
• Up-to-date knowledge of Quality guidelines (e.g., ICH, FDA, IMB, QMS, and GMP).
• Experience in project/people management for technology transfer projects.
• Sound technical knowledge of your specific field and a good understanding of critical on-site business functions.
• Detailed knowledge of cGMP requirements and Thermo Fisher Scientific’s Quality Policies, Management Procedures, and Guidelines.
• Familiarity with the Cork Risk Management System, CAPA’s, project planning & management.
• Excellent written and verbal communication skills.
  At Thermo Fisher Scientific, each one of our 100,000+ extraordinary minds have a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner, and safer

RESPONSIBILITIES:

You will play a pivotal role in maintaining the exceptional quality of our healthcare initiatives. Your technical prowess and dedication will contribute to the flawless execution of quality assurance processes. By providing proven analytical and technical support, you will ensure our quality infrastructure is extraordinary and ready to support the introduction of new products. Your commitment to quality and safety will help maintain our facility as an inspection-ready site. Furthermore, you will actively participate in the continuous improvement of the QA group, making it a true center of excellence.

WHAT WILL YOU DO?

• Conduct method development, validation/qualification, and transfer of quality methods.
• Prepare, review, and update quality methods and specifications.
• Compile QC handover packages and provide technical support during method familiarization and validation periods.
• Drive innovative ideas for new quality assurance methods and continuously optimize existing ones.
• Collect, interpret, and characterize quality data through accurate documentation of experimental results.
• Prepare and review quality-related change controls, study protocols, project status reports, and other relevant documentation.
• Expand your scientific and technical knowledge by knowing the latest in peer-reviewed literature, attending conferences, and participating in relevant training.
• Ensure timely project delivery while meeting technical, quality, and safety metrics.
• Perform all quality, regulatory, and safety duties with due care, aligning with our values: Integrity, Intensity, Innovation, and Involvement.
• Hands-on experience with HPLC, GC, and other essential instruments (FTIR, UV spec, Balance, pH, etc.) is required. Experience in LC-MS, GC-MS, and NMR is an asset

QUALITY RESPONSIBILITIES:

• Perform duties with the highest standard of accuracy and in strict accordance with our Quality Management System requirements and Global Quality Policies.
• Fully engage in our site’s quality initiatives and ensure alignment with all relevant standards.
• Attend training sessions and complete assessments to improve your skills and knowledge.
• Follow GMP quality compliance and always be inspection-ready
• Demonstrate behaviors that we value, including effective communication, facilitation, and presentation skills.
• Exhibit leadership qualities, influencing and negotiating skills, and a positive, can-do approach.
• Possess the ability to coach, empower, train, and mentor others.