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
Scientist Quality Assurance and Process Care
Builds
IVD products for allergy and autoimmune diagnostics
Domain
Life Sciences / In Vitro Diagnostics / Immunodiagnostics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Enzyme immunoassays (EIAs) development and production, GMP/GLP compliance, method validation and transfer, regulatory knowledge (FDA, EMA, ISO, ICH), data analysis and statistical evaluation, laboratory documentation, LIMS usage, corrective and preventive actions (CAPA), project management
Preferred skills
Chemistry, Biochemistry, Biology, or Microbiology background, technical writing for SOPs, mentoring staff, cross-functional collaboration
Technologies
LIMS, Microsoft Office (Excel)
Responsibilities
Perform quality control testing of EIAs, antigens, raw materials, and reagents; Provide technical guidance and supervision to technical staff; Investigate and resolve deviations and customer complaints; Prepare and review study reports and standard operating procedures (SOPs); Support regulatory audits and process improvements
Seniority
Mid-Senior, hands-on IC
