QC Analyst

Job Description 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.

 

Job Description

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

 

Skills Desired

Continued Learning, Dealing With Ambiguity, Decision Making Skills, Gxp, Industry Standards, Laboratory Equipment, Laboratory Excellence, Quality Control (Qc) Testing, Quality Control Sampling, Self-Awareness, Technological Expertise, Total Quality Management