QC Specialist Sample Management NPI; m​/w​/d

Position

QC Specialist Sample Management NPI (m/w/d)

Location:

Schaffhausen, Switzerland

Work hours:

80%–100%

• Plan, organise and conduct sampling and distribution activities during the introduction of new pharmaceutical products (NPI) from internal and external production.
• Serve as the central point of contact (Single Point of Contact) for NPI Sample Management for local and global stakeholders.
• Participate in local and global meetings for product and method transfers.
• Review manufacturing protocols regarding sampling strategies during NPI production at internal and external sites.
• Collaborate closely with various local and global functions (e.g. Planning, Production, Logistics, QC NPI, QA, external partners) to support timely product introductions.
• Plan and execute sample shipments to external test laboratories and document analytical results in eLIMS.
• Create sampling templates, sample labels and provide equipment for sampling in production.
• Perform and document temperature assessments for sample and drug transport.
• Conduct visual inspections of primary‑packaged sterile products (vials and syringes).
• Support the creation and maintenance of SOPs and work instructions in Sample Management.
• Assist in investigating deviations and defining corrective and preventive actions (CAPA).

• Completed natural science or technical degree, preferably with a focus in pharmaceutical, chemical or biotechnological fields, or several years of experience in a GMP‑regulated pharmaceutical quality environment.
• Several years of experience in a GMP‑regulated environment, preferably in the Quality Control domain.
• Experience verifying analytical data and reviewing GMP documents.
• Excellent proficiency in German and English, both written and spoken.
• Strong organisational skills and a customer‑orientated "Can‑do" mindset.
• Ability to manage multiple topics simultaneously, proactively coordinate and communicate activities, and set priorities.
• Proficiency with Microsoft Office applications.
• Experience with SAP, eLIMS and Comet is advantageous.

At Johnson & Johnson we provide an inclusive work environment where each person is valued as an individual. Diversity and the dignity of our employees are respected and their merit recognised.