Job Description

　　At Thermo Fisher Scientific team, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.

　　Location/Division Specific Information

　　Warrington Operations, Cheshire UK

　　A day in the Life:

　　As part of the Quality Team you will assure the quality of current and future products and satisfy the very high expectations of our customers. You will achieve this by collaborating closely with other functions and departments to identify solutions for diverse challenges as well as independently striving for continual improvement of Quality Management System processes.

　　Keys to Success:

　　Provide guidance in all areas of the Quality Management System, including, corrective & preventive actions, product complaints, post market surveillance, change control, nonconformance, Out of Specification processes, risk management, and internal and external audit support.

　　To check batch records during QA 3 tier review, ensuring GDP and critical manufacturing processes are executed as stipulated on processing documents and allow quality assurance of released materials.

　　Actively participate in New Product Development core teams ensuring risks within manufacturing and customer workflows are represented, also reviewing design history documents providing QA oversight to ensure compliance and document deliverables meet design requirements.

　　To be present in the manufacturing areas, to mentor and provide guidance to all teams, to assist with issue management, reviewing compliance and quality assurance in relation to customer needs.

　　Education

　　Degree in a scientific field or equivalent experience in a relevant disciplineExperience

　　Demonstrated ability in a regulated industry –Pharma or Biotech as examples

　　Experience of operating within a quality management system such as ISO13485

　　Knowledge, Skills, Abilities

　　Knowledge of 13485 and internal auditing helpful

　　Knowledge of risk assessment in line with ISO14971

　　Experience with Quality Improvement Tools (5 Why/pareto analysis/Run Charts)

　　Experience of CAPA processes & problem solving within Process/Product Improvement multi-functional teams

　　Ability to coach and influence others is crucial

　　Travel requirements – some travel maybe required – 10% max

　　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.

　　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.

　　Accessibility/Disability Access

　　Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

　　*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

　　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.