The individual in this position should have a working knowledge of the cGMP QC laboratory environment and laboratory equipment associated with biopharmaceutical analysis. The QC Biochemistry Senior Analyst is responsible for providing technical and laboratory support to the QC analysts in Alexion Dublin specifically working with the team to troubleshoot issues that may arise. The position requires the ability to understand and follow written SOPs, to accurately and legibly record work in real time, and pay close attention to detail. The individual must be able to 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, as trained and qualified: Gel electrophoresis (SDS-PAGE, IEF), ELISA and plate based assays (potency and residual assays such as HCP and ProA)
* Stability scheduling and testing.
* Recognize and report aberrant test results and sample conditions.
* Provide QC SME and day to day technical guidance to QC biochemistry analysts.
* Training of new analysts in specific assays.
* Drive continuous improvement initiatives within the QC department.
* Lead and complete execution of investigations/CAPAs in a timely manner.
* Provide lab support including reagent preparation, cleaning, and routine equipment maintenance.
* Ensure training is current for all job functions performed.
* Order, stock and receive laboratory supplies.
* Complete all required documentation legibly and accurately.
You will need to have:
* BSc in Chemistry or a biological science, with 4-7 years’ experience, or equivalent combination of education and experience.
We would prefer for you to have:
* A working knowledge of the cGMP QC laboratory environment, and equipment associated with testing of biopharmaceutical products
* Ability to follow written procedures with close attention to detail
* Ability to function with minimal supervision for routine job duties.
* A working knowledge of gel electrophoresis and ELISA assays
Date Posted: 13-Feb-2025
Closing Date: 27-Feb-2025
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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