QC Senior Analyst

at  Alexion PharmaceuticalsInc

THIS IS WHAT YOU WILL DO:

Strong working knowledge of the cGMP QC laboratory environment and laboratory equipment
associated with biopharmaceutical analysis. Responsible for providing technical and laboratory support to
the QC analysts in Alexion Dublin specifically working with the team as a trouble-shooter Possess the
ability to understand and follow written SOPs, to accurately and legibly record work in real time, and pay
close attention to detail. Perform routine tasks with a minimum of supervision.

YOU WILL BE RESPONSIBLE FOR:

• Perform all lab functions in compliance with cGMP.
• Follow written procedures for the following tests (and review of these tests), as trained and qualified:
• Electrophoresis (SDS-PAGE, IEF, iCE, CE-SDS).
• HPLC methods including Size Exclusion, Reverse Phase, Peptide Mapping, Anion Exchange and Dionex IC methods such as TSAC (HPAEC-ED).
• Microplate assays and ELISA.
• Protein Concentration.
• Compendial Methods such as pH, Osmolality, and Appearance.
• Stability scheduling and testing.
• Recognize and report aberrant test results and sample conditions.
• Ensure training is current for all job functions performed.
• Provide QC SME and day to day technical guidance to QC analyst personnel.
• Support the QC management team as required.
• Lead and complete execution of investigations/CAPAs in a timely manner,
• Training lead in specific assays overseeing the execution of all training activities for all new personnel.
• Drive continuous improvement initiatives within the QC department.