This Is What You Will Do
The QC Batch Release / Chemistry Support Analyst will support the QC department with emphasis on QC review and environmental monitoring batch release. The analyst will also support chemistry product testing for drug product and drug substance manufacture at Alexion Athlone and provide technical support with regard to testing and review. The analyst will be an SME on product testing and will participate in training and investigations as needed.
You Will Be Responsible For
Perform technical review of data generated in laboratory, validation protocols and reports.
Perform technical review of data generated during environmental monitoring.
Facilitate laboratory investigations and support associated product investigation.
Complete project work and implement initiatives designed to improve the efficiency of the laboratory function/department.
Support the QC department in internal and external audits where appropriate.
Maintain competence and keep up to date with all new technologies, procedures and methods used in the QC laboratories.
Perform chemistry product testing for drug product and drug substance manufactured at Alexion Athlone.
You Will Need To Have
Minimum of 5 years of experience in a cGMP quality environment.
Working knowledge of cGMP in a QC laboratory environment and laboratory equipment associated with biopharmaceutical analysis.
Ability to understand and follow written SOPs, accurately and legibly record work in real time, and pay close attention to detail.
Ability to perform routine tasks with a minimum of supervision.
Strong technical writing and report writing skills.
Experience in the use of gLIMs.
We Would Prefer For You To Have
Familiarity with continuous improvement methodologies such as Six Sigma or Lean.
Experience working in a global and diverse work environment.
Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.
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