Quality Specialist
Datum: 12.06.2026
Standort: Deutschland
Unternehmen: terumoeuro
At Terumo, we advance lifesaving medical technologies to benefit society. Are you eager to make a difference with us? Here, you’ll grow your expertise while staying true to your personal aspirations.
Guided by our Japanese heritage, we act with respect, take ownership, and pursue continuous improvement. If you see yourself in our values, keep reading; this might be the opportunity you're looking for
Department Info
You will join the Quality Assurance (QA) team within our CDMO plant in Leverkusen. The QA Operations team plays a key role in ensuring that all manufacturing, testing, engineering and warehouse activities comply with GMP standards and internal quality requirements.
Working closely with Manufacturing, Engineering, QC and Supply Chain, the team provides on-the-floor QA oversight, supporting operations to ensure safe, compliant and efficient production of biological products.
Job Summary
As a QA Operations Specialist, you ensure that daily operations across manufacturing, quality control, engineering and warehousing are fully compliant with GMP and internal procedures.
You will act as a key QA partner on the shop floor, providing guidance, performing document reviews, and supporting quality events such as deviations, CAPAs and change controls. In addition, you will play an important role in qualification and validation activities, ensuring these are executed in line with regulatory expectations. This position reports to the QA Ops Team Leader, Zhenda Wu.
Job Responsibilities
- Bachelor’s, Master’s or PhD in Life Sciences (e.g. Chemistry, Biochemistry, Microbiology, Biology or related field)
- Minimum 3 years of experience in a GMP-regulated environment (QA, QC, Manufacturing or Technical Operations)
- Experience with biological or biopharmaceutical products is an advantage
- Strong knowledge of GMP and regulatory standards (EMA, FDA, ICH, WHO)
- Proactive mindset with the ability to influence and drive improvements
- Strong communication, organisational and stakeholder management skills
- Comfortable working in an operational shop floor environment
- Experience with SAP and Microsoft Office tools
- Fluent in German and English
- Willingness to work in shifts when required
Profile Description
- Bachelor’s, Master’s or PhD in Life Sciences (e.g. Chemistry, Biochemistry, Microbiology, Biology or related field)
- Minimum 3 years of experience in a GMP-regulated environment (QA, QC, Manufacturing or Technical Operations)
- Experience with biological or biopharmaceutical products is an advantage
- Strong knowledge of GMP and regulatory standards (EMA, FDA, ICH, WHO)
- Proactive mindset with the ability to influence and drive improvements
- Strong communication, organisational and stakeholder management skills
- Comfortable working in an operational shop floor environment
- Experience with SAP and Microsoft Office tools
- Fluent in German and English
- Willingness to work in shifts when required
Offer
Contact Person
Working at Terumo means advancing healthcare with heart. Here, you are empowered to grow your own way, inspired to create to innovate, and supported as we get there together. Join us in shaping a healthier future for our patients, society, and each other.