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

Phadia GmbH; Freiburg im Breisgau; Vor Ort; EUR 55.000 - 75.000; Vollzeit

Benefits dieser Stelle

Company pension

Fringe benefits

Zusammenfassung

Phadia GmbH, Freiburg, part of Thermo Fisher Scientific, seeks a qualified QA/ QC scientist to support IVD product quality control and regulatory-compliant testing within a GMP/GLP environment. You will guide technical staff, participate in method development and product transfers, and drive CAPA and improvements across R&D and Production.

Advanced degree or extensive GMP/GLP experience is expected, with fluency in German and English and strong data, SOP writing, and project-management skills.

Qualifikationen

• Extensive GMP/GLP laboratory experience required.
• Knowledge of regulatory requirements and quality systems.
• Experience with method transfer and validation is a plus.

Aufgaben

• Provide scientific support for quality control and QA of IVD products for autoimmune diseases.
• Perform quality control testing of EIAs, antigens, raw materials, and reagents.
• Provide technical guidance to staff and supervise technicians.
• Support transfer of products from development to routine operations with R&D and Production.
• Drive continuous improvement and CAPA activities; resolve deviations and complaints.
• Prepare and review study reports and SOPs compliant with ISO/GMP.

Ausbildung

Advanced degree + GMP/GLP experience

Bachelor's degree + extensive GMP/GLP experience

Regulatory knowledge (FDA, EMA, ISO, ICH)

Data analysis & statistics

Technical writing (SOPs, reports)

LIMS & quality systems experience

Investigation leadership & CAPA

Project management & organization

German & English communication

Tools

LIMS

MS Office (Excel)

Jobbeschreibung

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

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of , color, religion, _ , orientation, gender identity, national origin, disability or any other legally protected status.