Quality Assurance Deviation Specialist (m/f/d)

About the role

The Deviation Specialist will join a large‑scale mammalian cell culture facility to own and investigate deviations, ensuring compliance with cGMP standards, product quality, and continuous improvement. This six‑month fixed‑term position supports critical quality activities in a highly regulated biotech environment.

Key responsibilities

• Own, document, and investigate deviations in alignment with cGMP requirements.
• Collaborate with subject‑matter experts and stakeholders to determine root causes and assess product or system impact.
• Apply structured investigational tools such as Fishbone, Fault Tree, and Event & Causal Factors analysis.
• Define effective corrective and preventive actions (CAPAs) and conduct effectiveness checks.
• Drive timely closure of quality records and support process‑improvement initiatives.

Required profile

• Bachelor’s degree in chemistry, biotechnology, life sciences, or a related field.
• Experience with deviation handling and cGMP environments in pharma or API manufacturing is a strong advantage.
• Knowledge of biotech manufacturing processes and analytical methods is beneficial.
• Familiarity with Human & Organizational Performance and risk management is a plus.
• Strong technical writing and communication skills; fluency in English (German is a plus).
• Structured, organized, proactive, and open to change.

Required skills

• Deviation management
• Mammalian genetics
• cGMP compliance
• Root cause analysis (Fishbone, Fault Tree, Event & Causal Factors)
• CAPA development and effectiveness verification
• Risk management