This is what you will do: 

The QC Analyst will support Chemistry and Microbiological product testing and environmental monitoring for Drug Product and Drug Substance manufacture at Alexion Athlone. The QC analyst will also provide technical support with regard to facility testing oversight, test method validation and introduction of new technology to the laboratory. The QC analyst will be an SME on product testing and environmental monitoring with responsibility for investigation and report writing. 

You will be responsible for: 

• Perform analytical testing and environmental monitoring sampling and testing for all cleanroom facilities. 

• Ensuring high cGMP and GLP standards are maintained while testing by adapting a right first time approach 

• Ensure all safety requirements within the lab are adhered to at all times and identify and escalate any safety concerns appropriately. 

• Adherence to schedules and targets to meet regulatory and business requirements. 

• Validation/Qualification of Microbiology and Chemistry analytical test methods and testing systems including the generation of associated reports. 

• Represent QC department in internal and external audits where appropriate and close out of actions/ recommendations identified from both internal and external audits. 

• Perform technical review of data generated in laboratory, validation protocols and reports and provide technical support to Manufacturing and Projects 

• Actively identify and implement continuous improvement initiatives with the QC lab 

• Investigate out of specification/limit results utilizing Structured Problem Solving, Root Cause Analysis tools in conjunction with the Laboratory Supervisor, QA and other relevant departments and to implement effective corrective and preventative actions while ensuring all investigations are closed with the specified lead-time. 

• Order, stock and receive laboratory supplies.  

• Provide lab support including reagent preparation, cleaning, and routine equipment maintenance. 

• Ensure training is current for all job functions performed. 

• Support training of other analysts within the QC lab  

• Receive and manage samples that come into the lab for testing to ensure that all samples are tested appropriately in a timely manner, including review/authorisation  

• Perform QC support activities such as sample shipments, CoA review, batch pack review and material release as appropriate 

• Prepare and present monthly and quarterly Environmental Monitoring trends 

• Preparation of annual Environmental Monitoring reports 

• Coordinate and track all alert/action excurions for the QC team

You will need to have:

• BSc (Hons) in biosciences (e.g. Microbiology/Chemistry etc.) and 3 years’ experience 

• The individual in this position should have a working knowledge of cGMP in a QC laboratory environment and  laboratory equipment associated with biopharmaceutical analysis.   

• 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. 

• The individual should have a strong understanding of lab safety and demonstrated ability to recognize and mitigate safety risks. 

• Strong technical writing and report writing skills 

• Experienced in the use of gLIMs 

We would prefer for you to have: 

• Experience in both Chemistry (HPLC, UV) and microbiological techniques 

Date Posted

Closing Date