About this role
The QC Biochemistry Analyst works in a cGMP QC laboratory environment focused on biopharmaceutical analysis. You need working knowledge of laboratory equipment, ability to follow written SOPs, record work accurately in real time, and pay close attention to detail. Perform routine tasks with minimal supervision under the QC Biochemistry Supervisor.
Day-to-day involves performing all lab functions in compliance with cGMP, following procedures for gel electrophoresis (SDS-PAGE, IEF) and ELISA plate-based assays including potency and residuals like HCP and ProA. Prioritize samples for release, stability, and in-process testing. Review laboratory data, logbooks, and test executions while recognizing aberrant results.
In this team environment, train new analysts in specific assays and provide lab support such as reagent preparation, cleaning, and routine equipment maintenance. Order, stock, and receive laboratory supplies. Ensure training remains current for all job functions performed.
Growth opportunities include driving continuous improvement initiatives within the QC department and completing execution of investigations in a timely manner with real-time updates. Complete all required documentation legibly and accurately. Contribute to an inclusive and equitable environment at Alexion.
Requirements
- BSc in Chemistry or a biological science with 1-4 years’ experience, or equivalent combination of education and experience
- Working knowledge of the cGMP QC laboratory environment and equipment associated with biopharmaceutical testing
- Ability to follow written procedures with close attention to detail
- Ability to function with minimal supervision for routine job duties
- Working knowledge of gel electrophoresis and ELISA assays
Responsibilities
- Perform all lab functions in compliance with cGMP
- Follow written procedures for gel electrophoresis (SDS-PAGE, IEF) and ELISA plate-based assays (potency, HCP, ProA)
- Prioritise samples for release, stability, and in-process testing
- Review laboratory data, including logbooks and test executions
- Recognise and report aberrant test results and sample conditions
- Train new analysts in specific assays
- Drive continuous improvement initiatives within the QC department
- Complete execution of investigations in a timely manner with real-time updates
Benefits
- Inclusive and equitable work environment
- Reasonable adjustments and accommodations available
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