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

Description

The role sits in quality assurance and process care at the German subsidiary of the Immunodiagnostics division, in Freiburg. The division makes in vitro diagnostics for allergy and autoimmune diseases, including fully automatic blood analysis systems used by clinicians.

The parent group has about $40 billion in annual revenue and more than 100,000 staff. The team's customers expect consistently reliable quality, which the company supports through biochemical and medical technology solutions and skilled staff.

The position is office-based, on a standard Monday to Friday schedule.

Responsibilities

• Give scientific support to quality control and quality assurance of in vitro diagnostic (IVD) products for autoimmune diseases.
• Run quality control tests on enzyme immunoassays (EIAs), antigens, raw materials and reagents, for routine production and development projects, using advanced analytical methods.
• Lead and supervise technical staff.
• Take part in developing and introducing new products and analytical instruments, including LIMS integration.
• Move products and test methods from development into routine work, coordinating closely with R&D and Production.
• Contribute to product lifecycle management and process optimisation, covering manufacturing and testing procedures and production equipment.
• Lead continuous improvement work.
• Investigate deviations and customer complaints, and define corrective and preventive actions (CAPA) and further improvements.
• Work with cross-functional teams to fix quality problems, support regulatory audits and deliver process changes.
• Write and review study reports and standard operating procedures (SOPs) that meet applicable ISO and GMP requirements.

Requirements

• Hold an advanced degree and several years of experience, or a bachelor's degree and many years of experience, in a GMP/GLP regulated laboratory.
• Preferred fields of study: chemistry, biochemistry, biology, microbiology or a related scientific field.
• Have deep knowledge of developing, producing or controlling enzyme immunoassays (EIAs).
• Understand regulatory requirements well, including FDA, EMA, ISO and ICH guidelines.
• Have experience with method validation, method transfer and verification.
• Analyse data, trends and statistics with confidence.
• Show proven skill in laboratory documentation and GMP compliance.
• Write clearly and precisely for SOPs, protocols and investigation reports.
• Have experience with LIMS and quality management systems.
• Have a track record of leading investigations and putting corrective actions in place.
• Manage projects and organise your work well.
• Communicate well with others and mentor colleagues.
• Work independently as well as within cross-functional teams.
• Use Microsoft Office well, especially Excel.
• Speak and write German and English well.

Conditions

Work Monday to Friday in the office.

The company is an equal opportunity employer and does not discriminate on protected grounds. Accessibility support during applications is available on request.

Benefits

• Work at a future-focused organisation with strong career and development prospects.
• Company pension scheme and other fringe benefits.
• A culture built on integrity, intensity, involvement and innovation.