QC Analyst

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:

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. Plan, implement, and evaluate routine and special analyses in a GMP-regulated environment independently.
3. Interpret test data, prepare detailed reports, and maintain accurate records of test results.
4. Troubleshoot testing procedures and recommend 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 with internal teams to optimize quality control processes.
8. Manage instrument responsibilities, including qualification, maintenance, and calibration documentation.
9. Support in maintaining the laboratory's inspection readiness.

Key Performance Indicators

1. Timely completion and accurate processing of test records.
2. Prompt reporting of missed deadlines and minimizing lead times.
3. Maintaining continuous readiness for inspection.
4. Adherence to GMP and GSU guidelines, SOPs, and avoiding critical irregularities.
5. Proactively identifying and implementing cost-reduction measures.
6. Completing all training as per the plan.

Minimum Requirements

1. Completed scientific education (e.g., Laboratory Technician, Bachelor’s or Master’s degree).
2. Experience in a GMP-regulated laboratory with documentation skills.
3. Knowledge of analysis techniques, especially HPLC and photometry; microbiological knowledge is advantageous.
4. Experience in a pharmaceutical laboratory environment.
5. Good IT skills (MS Office) and familiarity with laboratory software like LIMS, Chromeleon, Empower is a plus.
6. Ability to work accurately, independently, and proactively.
7. Reliability, flexibility, resilience, and strong teamwork skills.
8. Shift work with regular hours, including weekends.

Skills

1. Continuous learning
2. Handling ambiguity
3. Decision making
4. GMP standards
5. Industry standards
6. Laboratory equipment proficiency
7. Laboratory excellence
8. Quality Control (QC) testing and sampling
9. Self-awareness
10. Technological expertise

Languages

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

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