QC Analyst

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:

1. Conduct and coordinate quality control tests on biologics drug substances (Physicochemical testing, e.g., HPLC, Capillary Electrophoresis, UV) ensuring compliance with regulatory requirements.
2. Independent planning, implementation, and evaluation of routine and special analyses in a GMP-regulated environment.
3. Interpret test data, prepare detailed reports, and maintain accurate records of test results.
4. Troubleshoot testing procedures and make recommendations for improvements, focusing on HPLC and Capillary Electrophoresis.
5. Conduct microbiological tests such as total germ count determinations (MET) and bacterial endotoxins (BET).
6. Participate in the validation of analytical procedures.
7. Collaborate closely with internal teams to optimize quality control processes.
8. Manage instrument responsibilities, including qualification, maintenance, and calibration documentation.
9. Support in maintaining the laboratory in a ready state for inspection.

Key performance indicators:

1. Timely test record completion and accurate processing without delays.
2. Prompt reporting of missed deadlines and minimizing lead times.
3. Maintain continuous readiness for inspection.
4. Adhere to GMP and GSU guidelines and SOPs, avoiding critical irregularities.
5. Proactively identify and implement cost-reducing optimizations.
6. Complete all assigned training as per the plan.

Qualifications:

• Completed scientific education (e.g., Laboratory Technician, Bachelor or Master).
• Practical experience in a GMP-regulated lab and document creation.
• Knowledge of analysis techniques, especially HPLC and photometry; microbiological knowledge is advantageous.
• Experience working in a pharmaceutical laboratory environment.
• Good IT skills (MS Office) and familiarity with laboratory software like LIMS, Chromeleon, Empower is a plus.
• Ability to work precisely, independently, and proactively.
• Reliability, flexibility, resilience, and strong teamwork skills.
• Willingness to work a single shift including weekends.

Skills:

• Continuous learning
• Dealing with ambiguity
• Knowledge of industry standards
• Laboratory equipment handling
• Laboratory excellence
• Quality Control testing and sampling
• Self-awareness
• Technological expertise

Languages:

• Fluent in German (spoken and written) and proficient in English.

Why Novartis:

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting, and inspiring each other to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? Learn more

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