QC Analyst - Basel
Summary
We are seeking a motivated QC-Analyst for Biopharmaceutical Production within the framework of raw materials, drug substance, and in-process controls. The candidate will perform analytical testing and ensure compliance with SOPs, analytical methods, and compendial standards.
About the Role
Major accountabilities:
- Conduct and coordinate quality control tests on biologics drug substances (Physicochemical testing, e.g. HPLC, Capillary Electrophoresis, UV) ensuring compliance with regulatory requirements
- Independent planning, implementation, and evaluation of routine and special analyses in a GMP-regulated environment
- Interpret test data, prepare detailed reports, and maintain accurate record of test results.
- Troubleshoot testing procedures and make recommendations for improvements, with a focus on HPLC and Capillary Electrophoresis
- Conducting microbiological tests such as total germ count determinations (MET) and bacterial endotoxins (BET)
- Participate in the validation of analytical procedures
- Collaborate closely with the internal teams to optimize quality control processes
- Instrument responsibilities, including qualification, maintenance, and calibration documentation
- Support in ensuring that the laboratory is maintained in a ready state of inspection.
Key performance indicators:
- Timely test record completion and accurate processing without delays
- Prompt reporting of missed deadlines and aim for shortest possible lead times
- Continuous readiness for inspection
- Consistently follow the GMP and GSU guidelines, and SOPs, ensuring no critical irregularities
- Proactively identify and implement cost-reducing optimizations
- Complete all assigned training as per the provided plan
Minimum Requirements:
- Completed scientific education (e.g., Laboratory Technician, Bachelor or Master)
- Practical experience in a GMP-regulated lab and document creation
- Knowledge in common analysis techniques, especially HPLC and photometry; microbiological knowledge is an advantage
- Working experience in laboratory environment in the pharmaceutical industry
- Good IT skills (MS Office) and laboratory software like LIMS, Chromeleon, Empower are an advantage
- Ability to work precisely, independently, and proactively
- Reliability, flexibility, resilience, and strong teamwork skills
- Shift work with normal working times (one shift) including weekends
Skills:
- Continuous learning
- Dealing with ambiguity
- Decision making
- GMP
- Industry standards
- Laboratory equipment
- Laboratory excellence
- Quality Control (QC) testing
- Quality Control sampling
- Self awareness
- Technological expertise
Languages :
- Fluent in German (spoken and written) and proficient in English
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