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Summary
We are seeking a motivated QC-Analyst for Biopharmaceutical Production focusing on raw materials, drug substances, 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.
* Plan, implement, and evaluate routine and special analyses in a GMP-regulated environment independently.
* Interpret test data, prepare detailed reports, and maintain accurate records of test results.
* Troubleshoot testing procedures and recommend improvements, especially for HPLC and Capillary Electrophoresis.
* Conduct microbiological tests such as total germ count (MET) and bacterial endotoxins (BET).
* Participate in the validation of analytical procedures.
* Collaborate with internal teams to optimize quality control processes.
* Manage instrument responsibilities, including qualification, maintenance, and calibration documentation.
* Support in maintaining the laboratory's inspection readiness.
Key Performance Indicators
* Timely completion and accurate processing of test records.
* Prompt reporting of missed deadlines and minimizing lead times.
* Maintain continuous inspection readiness.
* Adhere to GMP, GSU guidelines, and SOPs without critical irregularities.
* Identify and implement cost-effective improvements.
* Complete all required training as scheduled.
Minimum Requirements
* Completed scientific education (e.g., Laboratory Technician, Bachelor’s or Master’s degree).
* Practical GMP-regulated laboratory experience and documentation skills.
* Knowledge of analysis techniques, especially HPLC and photometry; microbiological knowledge is a plus.
* Experience working in a pharmaceutical laboratory environment.
* Good IT skills (MS Office), familiarity with LIMS, Chromeleon, Empower preferred.
* Ability to work precisely, independently, and proactively.
* Reliable, flexible, resilient, with strong teamwork skills.
* Shift work required, including weekends.
Skills
* Continuous learning and adaptability.
* Handling ambiguity and decision-making skills.
* Knowledge of GMP, industry standards, laboratory equipment, and quality control testing.
* Self-awareness and technological proficiency.
Languages
* Fluent in German (spoken and written) and proficient in English.
Skills Desired
Continuous learning, dealing with ambiguity, decision-making, GMP, industry standards, laboratory equipment, laboratory excellence, QC testing, sampling, self-awareness, technological expertise.
Why Novartis
Helping people with disease and their families requires more than science. It takes a community of passionate individuals working together to make breakthroughs that change lives. Join us to create a brighter future: Learn more.
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Benefits and Rewards
Discover how we support your growth in our benefits handbook.
Additional Details
* Seniority level: Entry level
* Employment type: Full-time
* Job function: Quality Assurance
* Industry: Pharmaceutical Manufacturing
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