Bioassay QC Specialist & Lab Operations Lead

Biopharma Asia; Schaffhausen; Hybrid; CHF 120,000 - 160,000; Full time

Job summary

Johnson & Johnson in Schaffhausen seeks a QC FF LM Specialist Bioassay Lab to lead the Quality Control Fill Large Molecules group. The role entails ensuring smooth lab operations, maintaining质量 standards, and driving cGMP documentation and CAPA processes.

You will coordinate new product transfers to routine analytics, develop methods, and work across international teams. Fluent German and English are required, with optional 80% part-time arrangement for suitable candidates.

Qualifications

• Team-oriented, communicative and proactive with high quality standards.
• Willingness to take leadership, coordination or project responsibilities.
• German and English fluent in speaking and writing.
• Ability to work in GMP-regulated laboratory environments.

Responsibilities

• Act as deputy lab head and ensure smooth operation within own area.
• Develop and review cGMP documents (equipment qualifications, SOPs, work instructions, trend reports).
• Create and edit laboratory deviations, CoCs & CAPAs; coordinate problem-solving activities.
• Coordinate transfer of new products to routine analytics; support new test methods and techniques.
• Conduct equipment qualifications and support cross-functional lab systems like iLAB or SmartQC.
• Collaborate with international teams on analytical issues and projects.
• Participate in audits by authorities and customers.
• Provide IPC analytics coverage and occasional night/holiday work as required.

Skills

Analytical Reasoning

Cross-Functional Collaboration

Quality Control

Problem Solving

Compliance Management

Quality Auditing

Quality Standards

Documentation

Process Oriented

Report Writing

Innovation

Persistence and Tenacity

Controls Compliance

Team Leadership

Education

Promotion or Master’s degree in a natural science

Tools

eLIMS

MS Office

Job description

Johnson & Johnson in Schaffhausen seeks a QC FF LM Specialist Bioassay Lab to lead the Quality Control Fill Large Molecules group. The role entails ensuring smooth lab operations, maintaining质量 standards, and driving cGMP documentation and CAPA processes.

You will coordinate new product transfers to routine analytics, develop methods, and work across international teams. Fluent German and English are required, with optional 80% part-time arrangement for suitable candidates.