Scientist Quality Assurance and Process Care (m/f/d)
Core
Provide scientific support for quality control and assurance of in vitro diagnostic (IVD) products for autoimmune diseases, performing testing on Enzyme immunoassays (EIAs), antigens, raw materials, and reagents.
Role type
Senior Quality Assurance Scientist (IVD)
Builds
Reliable and high-standard quality for allergy and auto-immune diagnostic products
Domain
Life Sciences / In Vitro Diagnostics / Medical Devices
Required skills
GMP/GLP compliance, Enzyme immunoassay (EIA) development and production, method validation and transfer, regulatory knowledge (FDA, EMA, ISO, ICH), data analysis and statistical evaluation, laboratory documentation, technical writing for SOPs, LIMS usage, CAPA implementation, project management
Preferred skills
Chemistry, Biochemistry, Biology, or Microbiology degree, extensive experience in GMP regulated environments, strong technical writing, mentoring staff, cross-functional collaboration
Technologies
LIMS, Microsoft Office (Excel), Enzyme immunoassay systems
Responsibilities
Perform quality control testing of EIAs, antigens, raw materials, and reagents; provide technical guidance and supervision to staff; support product development and LIMS integration; drive continuous improvement and resolve deviations; prepare study reports and SOPs in compliance with ISO and GMP requirements
Seniority
Senior, hands-on IC with leadership responsibilities