Descripción
The QC Associate is a hands-on person responsible for performing routine analytical testing in support of Quality Control and Process Development and performing general laboratory operations in support of mRNA drug substance and drug product manufacturing. He/she assists in the different aspects of the method lifecycle within QC to ensure that methods are fit for their intended purpose throughout the product lifecycle. The QC Associate is a member of the QC department. This position reports into the QC Manager and will be based in Niel, Belgium. Responsibilities and duties The QC Associate ’s duties shall include, but not be limited to: Primary responsibility will be performing general QC and Process Development routine characterization, release and stability testing and performing general laboratory operations including reagent preparation and qualification, sample/reagent/consumables stock management, equipment maintenance, lab housekeeping etc. Document and report data and results in accordance with the current procedures, protocols and cGMP regulations and interpret generated data for compliance towards method criteria and specifications. Report interim stability data, perform trending and write stability reports to determine the final product shelf-life and expiry date Assist in the phase-appropriate development, qualification/validation, implementation and transfer of QC methods (e.g., qPCR, Slot Blot, Western Blot, SDSPAGE, Spectrophotometry, Fluorimetry, Capillary Gel Electrophoresis, Sequencing, ELISA, Flow Cytometry, …) to support the manufacturing, characterization and release of DNA start material, raw materials, lipids, mRNA Drug Substance and Drug Product. Interact very closely with the Process Development department regarding analytical support in order to ensure that Process Development and QC activities are aligned with respect to process improvement. Write and revise procedures, protocols and reports to support the QC test method lifecycle. Assist