Scientist Quality Assurance and Process Care (m/f/d)

Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
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 complex 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 distributed team of over 100,000 colleagues provides an outstanding mix of brand new technologies, purchasing convenience, and pharmaceutical services across our top-tier brands like Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.
Location/Division Specific Information:
Phadia is the leading supplier of fully automatic blood analysis systems for allergy and auto-immune diseases. With our innovative products, we set standards worldwide and assist clinicians in providing fast and reliable diagnoses, thus helping patients at an early stage. Phadia GmbH in Freiburg is the German subsidiary of the Immunodiagnostics division of Thermo Fisher Scientific, a global company that develops, manufactures and distributes in vitro diagnostics in the field of allergy and autoimmune diagnostics. Our customers expect a consistently reliable and high standard of quality from our products, which we ensure through innovative biochemical and medical technology solutions as well as highly qualified and motivated employees.
A Day in the Life:
Provide scientific support for the quality control and quality assurance of in vitro diagnostic (IVD) products for autoimmune diseases
Perform quality control testing of Enzyme immunoassays (EIAs), antigens, raw materials, and reagents as part of routine production and development projects using advanced analytical techniques
Provide technical guidance and supervision to technical staff
Participate in projects related to the development and implementation of new products and analytical instruments, including LIMS integration
Support the transfer of products and test methods from development into routine operations, working closely with colleagues in R&D and Production
Contribute to projects focused on product lifecycle management and process optimization, including manufacturing and testing procedures as well as production equipment
Drive continuous improvement initiatives
Investigate and resolve deviations and customer complaints, and implement corrective and preventive actions (CAPA) and continuous improvement measures
Work with cross-functional teams to resolve quality issues, support regulatory audits, and implement process improvements
Prepare and review study reports and standard operating procedures (SOPs) in compliance with applicable ISO and GMP requirements
Keys to Success:
Advanced degree plus some years of experience, or Bachelor's degree plus many years of experience in GMP/GLP regulated laboratory environment
Preferred Fields of Study: Chemistry, Biochemistry, Biology, Microbiology or related scientific field
Extensive knowledge in development, production or quality control of Enzyme immunoassays (EIAs)
Strong understanding of regulatory requirements (FDA, EMA, ISO, ICH guidelines)
Experience with method validation, method transfer, and verification activities
Proficiency in data analysis, trending, and statistical evaluation
Demonstrated expertise in laboratory documentation and GMP compliance
Strong technical writing skills for SOPs, protocols, and investigation reports
Experience with LIMS and quality management systems
Proven ability to lead investigations and implement corrective actions
Excellent project management and organizational skills
Strong interpersonal skills and ability to mentor staff
Ability to work independently and as part of cross-functional teams
Good to excellent proficiency in Microsoft Office applications, particularly Excel
Excellent written and verbal communication skills in both German and English
What we offer:
Employment with an innovative, future-oriented organisation
Outstanding career and development prospects
Company pension scheme and other fringe benefits
Exciting company culture which stands for integrity, intensity, involvement and innovation
If you are interested, please apply online with your CV and Motivation Letter including possible start date.
At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
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, disability or any other legally protected status.
Apply today! http://jobs.thermofisher.com
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