QC Specialist

Department Info

Terumo Pharmaceutical Services (TPSG) in Leverkusen and Wuppertal is part of Terumo’s global Pharmaceutical Solutions division, supporting pharmaceutical and biotechnology companies with high-quality contract development and manufacturing services. The Quality Control department provides analytical testing services to support the release and stability assessment of biopharmaceutical products. Our expertise spans physicochemical testing, chromatography, electrophoretic methods, bioassays, and microbiological testing. Through expertise across these scientific disciplines, our teams ensure that products meet the highest quality, safety, and regulatory standards

Job Summary

As a QC Specialist, Separations, you will support analytical testing activities for biopharmaceutical products in a GMP-regulated Quality Control environment. The role includes routine testing and data review, planning and execution of method validations and method transfers, as well as management of deviations and change controls. In addition, you will serve as technical contact for clients on analytical topics, driving discussions and coordinating communication related to testing activities, method implementation, and project deliverables.

Job Responsibilities

• Perform routine testing of in-process, release, and stability samples in accordance with approved procedures, specifications, and GMP requirements.
• Serve as main contact for clients regarding analytical testing activities, method transfers, validations, investigations, and project deliverables.
• Review, evaluate, and document analytical results in compliance with GMP requirements.
• Plan, coordinate, and execute analytical method validations, method transfers, method verifications, and method qualifications.
• Author and review protocols, reports, analytical procedures, SOPs, and other GMP documentation.
• Lead investigations, including deviations, OOS/OOT events, CAPAs, and change controls.
• Contribute to laboratory operational excellence initiatives and promote a safe, organized, and inspection-ready laboratory environment.
• This position is primarily based in Wuppertal-Aprath and requires periodic presence at the Leverkusen site.

Profile Description

• Master’s or Bachelor’s degree in Chemistry, Pharmacy, Life Sciences, or a related scientific discipline.
• Minimum 3 years of experience in a Quality Control environment within the biopharmaceutical industry, preferably in a CDMO setting.
• Hands-on experience with separation techniques such as HPLC, UPLC, CE, and/or iCIEF.
• Strong knowledge of GMP requirements and their application within a QC laboratory.
• Experience working in a CDMO environment and understanding client-focused analytical support requirements.
• Fluent in English, both written and spoken.
• Proactive and solution-oriented mindset with the ability to take ownership of assigned activities.
• Strong communication and stakeholder management skills, including interactions with clients and cross-functional teams.
• Collaborative team player with a commitment to continuous learning and professional development.

Offer

At Terumo, we are committed to Advancing Healthcare with Heart. We offer:

• A meaningful role in an international healthcare company with a strong purpose
• A collaborative and quality-driven work environment
• Opportunities for professional development and continuous learning
• A culture of respect, teamwork, and continuous improvement
• Competitive compensation and benefits package

Contact Person

Please apply via the link in this job description.
Contact Person: Marjolein Buyl 
Feedback on this application will come after 28/07.