Position Summary The 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 the laboratory.Represent the QC department in internal and external audits.Own the closeout 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 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.Education 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.
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