QC Specialist - Alexion

Ireland
Permanent
Full-time

7 days ago

QC Biochemistry SpecialistReports to: QC Biochemistry ManagerLocation: DublinPosition SummaryThe individual in this position should have a strong working knowledge of the cGMP QC laboratory environment and laboratory equipment associated with biopharmaceutical analysis. The QC Biochemistry Specialist is responsible for providing technical and laboratory support to the QC analysts and QC Senior analysts in Alexion Dublin specifically working with the team as a trouble-shooter. The position requires the ability to understand and follow written SOPs, to record work accurately and legibly in real time, and pay close attention to detail. The individual must be able to perform routine tasks with a minimum of supervision.Principal Responsibilities

Perform all lab functions in compliance with cGMP
Follow written procedures and test methods, as trained and qualified.
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 for ELISA (potency and residual assays such as HCP and ProA) and gel electrophoresis methods.
Support the QC management team as required.
Lead and provide SME support of investigations, CAPAs, deviations and change controls in a timely manner.
Support and drive continuous improvement initiatives within the QC department.
Management of the critical reagents within the lab
Management and generation of Certs of Analysis.
Perform technical review and authorization of data generated in laboratory.
Represent the QC department in internal and external audits
Own the close out of actions/ recommendations identified from both internal and external audits.
Scheduling of work across teams.
SME in the development, operation, and evaluation of training/re-training programs.
To carry out other activities as requested by the QC Supervisor/Management.

Qualifications and key competencies

In depth knowledge of current regulatory requirements for Biochemistry methods in support of cGMP operations supporting clinical and commercial manufacturing
Good technical knowledge for Biochemistry ELISA and/or gel electrophoresis methods
Good experience in investigation methodology and method troubleshooting
Ability to follow written procedures with close attention to detail
Good report writing and technical writing skills.
Ability to function with minimal supervision for routine job duties

EducationBSc in Chemistry or a Biological science, 4-7 years’ experience, or equivalent combination of education and experience.Date Posted 09-Apr-2026Closing Date 21-Apr-2026Our 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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