QC Specialist / Senior Specialist in the Physicochemical Team

In this role, as a member of our growing Quality Control Phys-Chem team, you will be responsible for conducting physico-chemical analyses of products and raw materials. You will also serve as a mentor for more junior team members. This position is an opportunity for you to become a valuable expert in the biopharmaceutical industry

• participating in the project related to the launch of a new laboratory at the plant on biotechnology and other projects implemented in Quality Control;
• performing transfer and validation of physicochemical methods;
• performing qualitative and quantitative physicochemical tests in tested products and starting materials;
• verification of the correctness of test documentation in accordance with applicable procedures;
• collection and registration of clean media, raw materials, semi-finished products, products ready for analytical testing;
• participation in the development of the GMP system in the Quality Control Laboratory;
• Conducting investigations, corrective and preventive actions regarding the results of OOS, OOT and complaints regarding product quality;
• participation in the preparation of the Quality Control area for GMP audits and certification;
• working out of standard procedures, instructions and analytical methods as well as training in them;
• performing maintenance, calibration and qualification of laboratory equipment in accordance with applicable instructions and procedures.

• higher education, with a specialization in the fields: chemistry, biotechnology, biochemistry or related;
• experience of working in an analytical laboratory or quality control laboratory in pharmaceutical or biotech works, (at least 5 years);
• experience in working with instrumental analytical techniques in the field of physicochemical tests of biotechnological drugs and raw materials, including such as: chromatography (HPLC, UPLC, GC), UV/VIS spectrophotometry, FT-IR, capillary electrophoresis;
• practical and theoretical knowledge in the field of validation and transfer of analytical methods;
• knowledge of regulations and guidelines for good laboratory practice (GLP) and Good manufacturing Practice (GMP) contained in the ICH, FDA, EMEA and national guidelines;
• experience in testing of biotechnological products;
• minimum basic knowledge of statistical techniques;
• knowledge of MS Office pack;
• fluent English spoken and written;
• organizational and self solving problems skills;
• strong communication skills.

Supplementary information - contract for a fixed period of 18 months with the possibility of extension.