QC Analyst
On-site · Dublin, Leinster, Ireland
Job Summary
QC Microbiology Analyst responsible for environmental monitoring sampling and testing in a cGMP laboratory. Role supports environmental and facilities monitoring, testing to support release and stability programs, and adherence to GLP/cGMP standards. Will maintain high standards of housekeeping and safety, complete project work to improve laboratory efficiency, keep management informed of issues, and investigate out-of-spec results using root cause analysis with the Microbiology Laboratory Supervisor and QA. Will train laboratory personnel and contribute to training programs. Requires a degree in Microbiology or related science and a minimum of 1 year in a cGMP quality environment; experience with sterile/non-sterile pharmaceutical/biopharmaceutical testing and knowledge of regulatory requirements for Microbiology/Sterility Assurance.
Required Qualifications
- Degree in Microbiology or related science
- 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
- Ability to follow written SOPs and accurately record work in real time
- Ability to perform environmental monitoring sampling and testing
- Ability to train laboratory personnel and support development of training programs
- Capability to investigate out of specification/limit results using Structured Problem Solving and Root Cause Analysis tools
- Ability to work in a lab environment with hazardous materials and PPE
- Location: Dublin, Ireland (Ireland - Dublin College Park)
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