Job Title: Quality Specialist
Location: Vantaa, Finland
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 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 complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled 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 and Patheon. For more information, please visit www.thermofisher.com.
Our Finland locations include Vantaa and Joensuu, employing over 900 professionals supporting functions such as production, instrument and reagent manufacturing, R&D, marketing, sales, quality, administrative support and supply chain. We hire experts in different fields including engineering, chemistry, microbiology and bioinformatics. Our Vantaa site develops pipettes and microplate instruments as well as develops and manufactures magnetic particle processing systems as well as clinical chemistry and industrial chemistry analyzers, laboratory automation solutions and food safety kits. It is conveniently located close to the Vantaankoski railway station. Please read more about Finnish sites, innovative work and collaborative colleagues at https://jobs.thermofisher.com/global/en/finland.
Review the link below to meet the team with overview of the R&D Cascadion Clinical Mass Spectrometry Solutions by Thermo Fisher Scientific. https://lnkd.in/dF7EAZw
How will you make an impact?
Thermo Fisher Scientific has an excellent opportunity to be part of developing QARA team as a Quality Specialist. This position within the QARA team will provide quality oversight, support and knowledge to activities relating to Quality Management Systems across our Vantaa site. You will be accountable for the delivery of a robust Quality Management System to support a flexible, empowered and multi-skilled teamwork environment. In addition, the person will be supporting the site process related to qualifications, verifications and validations.
What will you do?
• • Author, support, review and approve Quality Management System Procedures as required to maintain regulatory compliance
• Process QMS documents in a Quality managing system tool and support process changes in in the quality management system
• Uses knowledge to improve Quality Management Systems, with willingness to provide support to other functions to enable continuous improvement
• Support supplier qualification and re-evaluation in collaboration with Sourcing team
• Provide quality support for validation, verification and instrument qualifications
• Giving quality insight for production transfer across contractors to include validation/verification activities
• Provide support and expertise for audit readiness activities, during authority audits including interaction with auditors and support internal activities concerning any identified nonconformities
• Assist the gathering, analysis and reporting of Quality System performance metrics via the Monthly reporting and Quality Management Review process
• Assist with the training of business units on quality and compliance matters
• Willingly accepts challenging assignments
How will you get here? (education, experience, skills & abilities)
• M.Sc. (or equivalent) degree in biochemistry, chemistry, engineering or related field and minimum 2 years of experience of working in in vitro diagnostic industry (or other regulated environment), or alternatively
• B.Sc. degree in relevant field with 3 years of experience of working in in vitro diagnostic industry (or other regulated environment)
• Experience from working with quality system requirements (especially EU and FDA)
• Excellent verbal and written communications skills in Finnish and English
• Attention to detail in setting, conducting, and documenting; records keeping in compliance with company policy and regulatory requirements (e.g. IVD Directive/Regulation and USA FDA QSR; ISO 13485)
• Good analytical, problem solving and root-cause analysis skills
• Ability to communicate efficiently with the experts in the other scientific and technical fields, and a willingness to learn new skills
• Ability to reach solution with confidence and integrity
• Experience performing internal audits (advantage)
• Experience in applying various statistical principles to sample size determination and result assessments (advantage)
Please send in your application, including a cover letter, CV and salary request in English. Please apply via http://jobs.thermofisher.com/ by 8th August. Please apply as soon as possible, the position will be filled as soon as suitable candidate is found. If you have questions about please contact Sini Sipponen, Quality Manager, Specialty Diagnostics Group +358 (10) 3292991 (on 30.6 from 09:00-10:00 am and 3.8. from 10:00-11:00 am.)
If you have questions about Thermo Fisher Scientific and/or the position - please contact John Kirtley, Sr Recruiter Nordics, email@example.com
Each one of our 75,000 extraordinary minds have a unique story to tell. It’s not just a career, it’s a chance to realize your best – professionally and personally.
Join us and contribute to our mission—enabling our customers to make the world healthier, cleaner and safer: http://jobs.thermofisher.com