Proclinical is currently recruiting for a QC Analyst with a leading biopharmaceutical company located in Switzerland. As the QC Analyst, you will plan and support execution of internal as well as outsourced analytical testing, analytical qualifications, and stability studies of exosomes, biological molecules, oligonucleotides, small molecules, and drug products.
- Provide support to the Quality Control Department by performing the following testing for materials and products: Endotoxin testing (LAL), Biological Indicators Evaluation, Dioptre, Power, Imagine Quality and Dimensional Inspection testing and packaging integrity.
- Collect water samples for testing (TOC, HPC, Conductivity) by external suppliers and analyse the results.
- Coordinate with external supplier for testing on Product and analyse the results.
- Coordinate with external supplier for Environmental Monitoring (e.g. viable and not viable particulate monitoring) and analyse the results.
- Conduct routine and non-routine analysis of raw materials, in-process items, and finished products.
- Compile data for documentation of test procedures that may include stability program testing and formulation studies.
- Support manufacturing activities
- Responsible for daily log activities including GLP compliance, compliance with safety regulations and maintenance of appropriate levels of needed lab supplies and equipment.
- Participate in IOQ and TMV activities
Skills and Requirements
- Bachelor's degree, preferable in the scientific field
- At least three years of experience in a similar role. Experience in Medical Devices and/or in a Pharmaceutical field is mandatory.
- Laboratory skills and FDA/ISO 13485 knowledge are indispensable.
- Excellent English skills, both spoken and written as well as very good German and/or French, also both spoken and written.
- Professional IT Skills (MS Office etc.)
- Very flexible and adaptable to change with ability to work under pressure.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.