QC Analyst

This is what you will do: 

The individual in this position should have a working knowledge of the cGMP QC laboratory environment and laboratory equipment associated with microbiological  analysis. The QC Microbiology Analyst is responsible for testing using Micro techniques, performing Environmental Monitoring and compilation of Trends in Alexion Dublin. 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. 

You will be responsible for: 

• ​​Environmental and Facilities monitoring sampling and testing. 

• ​Testing to support release and stability programs on site. 

• ​Ensuring high cGMP, GLP standards are maintained while testing and adherence to schedules and targets to meet regulatory and business requirements.  

• ​To ensure a high standard of housekeeping and safety is maintained in the Laboratory. 

• ​Completion of project work and implementation of initiatives designed to improve the efficiency of the laboratory function/department. 

• ​To keep management updated on issues arising within the laboratory. 

• ​Investigate out of specification/limit results utilizing Structured Problem Solving, Root Cause Analysis tools in conjunction with the Microbiology 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. 

• ​To train laboratory personnel and play appropriate role in the development, operation and evaluation of training/re-training programs. 

​​ 

You will need to have 

• ​​Minimum of 1 year  experience in cGMP Quality environment. 

• ​Experience in testing of sterile/non-sterile pharmaceutical /biopharmaceutical products. 

• ​Good knowledge of current regulatory requirements for Microbiology / Sterility Assurance in support of cGMP operations supporting clinical and commercial manufacturing. 

• ​Degree in Microbiology or related science. 

• ​The duties of this role are generally conducted in an lab environment.  As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/degown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.  

​​ 

We would prefer for you to have: 

• Experience/Knowledge of aseptic techniques