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

Thermo Fisher Scientific · Freiburg, Germany

RoleLantern checked active

QualityFull timeCompany career page

RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.

Role summary

Scientist Quality Assurance and Process Care role supporting quality control and assurance of in vitro diagnostic products for autoimmune diseases. Responsibilities include QC testing of enzyme immunoassays, technical oversight, method validation, and process optimization within a GMP-regulated environment.

What they're looking for

Advanced degree in Chemistry, Biochemistry, Biology, Microbiology, or related field, plus some years of experience; or Bachelor's degree plus extensive experience
Extensive knowledge of enzyme immunoassay (EIA) development, production, or quality control
Strong understanding of FDA, EMA, ISO, and ICH regulatory requirements
Experience with method validation, transfer, verification, and LIMS systems
Proficiency in data analysis, statistical evaluation, and technical writing for SOPs and protocols
Fluent in German and English, written and verbal
Strong project management and interpersonal skills with ability to mentor staff

What you'll be doing

Provide scientific support for quality control and assurance of in vitro diagnostic products
Perform QC testing of enzyme immunoassays, antigens, raw materials, and reagents using advanced analytical techniques
Lead investigations, implement corrective and preventive actions (CAPA), and resolve deviations and customer complaints
Support product transfer from development to routine operations and participate in product lifecycle management projects
Prepare and review study reports and SOPs in compliance with ISO and GMP requirements

Privacy & handoff

This role links to Thermo Fisher Scientific's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.

What RoleLantern checked

This role is listed from an approved source. RoleLantern checks that the application link is live and how recently the role appeared — the employer has not confirmed it directly on RoleLantern.

RoleLantern checked active

RoleLantern checkedNeeds clarity

Date posted2 days ago

Last source check1 day ago

Salary listedNeeds clarity

Location clearClear

Something look off? Let us know and we may ask the employer to verify it.

See how you match this role

Upload your CV to see which of this role's requirements your background supports, where there may be gaps, and what needs clarification. Private by default — we never sell your CV.

See my match