QC Analyst / QC Associate

Location: Stein
Duration: Until 31st July 2021
QC Laboratory for release and stability tests of biopharmaceutical products (antibodies) - planning, independent and timely execution of routine analyzes according to regulations / monographs of biotech products (antibodies)


. Strong analytical focus on biotechnological methods: HPLC by SEC, CEX and RP;Electrophoresis, capillary electrophoresis, UV / Vis spectroscopy.In addition, physical tests, e.g. osmolality, turbidity, pH, Karl-Fischer.
. Planning, independent and timely implementation of special, even complex analyzes, for example in the context of clarifications for OOE / OOS results, process validations, method transfers, etc
. Logging of the analysis results in compliance with the associated GMP guidelines.
. Checking the raw data, entering the results into SAP and creating analysis results.
. In-depth SAP knowledge (e.g. super user) of advantage or interest to undertake such a task is desirable
. Creation of simple reports (e.g. OOE / OOS)
.Activesupport of the team when technical or analytical problems occur
. Ensuring correct and timely calibration of analytical instruments and systems in the area of ​​responsibility
. Assistance with qualification (including documentation) of analytical instruments and systems in the area of ​​responsibility
. Cleanliness and maintenance of the laboratory area
. Keeping up-to-date and expanding the required knowledge in your own area or participation in further training events - Incorporation of new employees

. QC analysis of biotechnologically manufactured products (Biologics) under GMP
. Sound experience in HPLC methods (SEC, CEX, RP)
. Physical test points (including Karl Fischer, osmolality, turbidity)
. Sound knowledge of SAP and Chromeleon (eg power user) desirable