Engineer III, QA

As the world leader in serving science, our work is more than something that fills our days – what we do has great purpose. Our industry-leading scale means unparalleled commercial reach, unique customer access and a global footprint. Our broad customer base, from research to clinical to commercial production means you can have a broad and meaningful impact here at Thermo Fisher Scientific. All while working in an environment where you will be supported, valued and rewarded for your performance.

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner, and safer. Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, growing efficiency in their laboratories, improving patient health through diagnostics, or the development and manufacture of life-changing therapies, we are here to support them. Our global team of more than 100,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience, and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

Engineer III, QA

Thermo Fisher Scientific’s Mission is to enable our customers to make the world healthier, cleaner, and safer, and the global coronavirus (COVID-19) outbreak is a powerful reminder of the importance of that Mission! In fact, Thermo Fisher is at the forefront of the global response to COVID-19. We are working with governments, agencies, industry partners and researchers globally to ensure priority access to instruments, consumables, safety supplies and other products to address the outbreak. Our efforts have been particularly focused in supporting analysis of the virus, diagnosis, personal protection, and helping in the development of new therapeutics and vaccines!

We have an excellent opportunity for Analytical Development Scientist to join our team, in Cork, Ireland API site. 

Job 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.

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.

Work Schedule

• Standard (Mon-Fri)

Environmental Conditions

• Adherence to all Good Manufacturing Practices (GMP) Safety Standards, No eye contacts allowed; prescriptive glasses will be provided, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Apply today! http://jobs.thermofisher.com

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 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.