Senior QC Analyst

This is what you will do:

The QCBatch Release/ Chemistry Support Analystwill support the QC department with emphasis on QCreview and EM batch release.The QC Batch Release / Chemistry Support Analyst willalsosupportChemistry product testing for Drug Product and Drug Substance manufacture at Alexion Athlone. The QC analyst will also provide technical supportwith regard totestingandreview.TheQC analyst will be an SME on product testingand willparticipateintraining andinvestigations asneeded.

You willbe responsible for:

• Perform technical review of data generatedin laboratory validationprotocolsand reports.

• Perform technical review of data generatedduring Environmental Monitoring

• Facilitate laboratory investigations and support associated product investigation

• Completion of project work and implementation of initiatives designed to improve the efficiency of the laboratory function/department.

• Supportthe QC department in internal and external audits whereappropriate.

• Tomaintaincompetence and keep up to date with allnew technologiesproceduresand methods used in the QC Laboratories.

• Performchemistry product testing for Drug Product and Drug Substance manufacturedat Alexion Athlone.

You will need to have:

• Minimum of5years of experience incGMPQuality environment.

• The individual in this position should have a working knowledge of cGMP in a QC laboratory environmentand laboratoryequipment associated with biopharmaceutical analysis.

• The position requires the ability to understand and follow written SOPs toaccurately and legibly record workin real time and pay close attention to detail.

• The individual must be able to perform routine tasks with a minimum of supervision.

• Strong technical writing and report writing skills

• Experienced in the use ofgLIMs

We wouldpreferfor you to have:

• Familiarity with continuous improvement methodologies such as Six Sigma or Lean.

• Experience working in a global and diverse work environment.