QC Senior Analyst
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.
You will need to have:
- BSc in Chemistry or a biological science, 4-7 years’ experience, or equivalent combination of education
- and experience.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.