Our client is a leading global Biotechnology company who have setup a state of the art single use bioreactor greenfield facility just outside of Dublin. The QC Analyst role will support the Microbiology Laboratory Start-up activities at their new single use multi-product biotech facility based in Leinster. The overall responsibility for this role will be to support the Microbiology Quality Control testing function, ensuring compliance with cGMP and corporate regulations.
The QC Analyst will work within the Micro lab and some of their responsibilities will include but are not limited to the following;
- Conducting microbiology analysis- bioburden testing, endotoxin testing, microbial identification
- Carrying out environmental monitoring including viable and non-viable particulate monitoring and water testing in the manufacturing facility
- Participating in the technical transfer/validation /verification of microbiological and analytical testing procedures
- Investigating Out of Specification (OOS) and Out of Trend (OOT) results, Non-Conformances, Corrective actions, CAPAs etc
- Adhering to the Quality Control (QC) documentation system and preparing and reviewing document change requests as required
The successful candidate will have the following;
- A bachelor's degree in microbiology, biochemistry, chemistry, or an engineering discipline
- Experience working in Microbiology in the pharmaceutical industry, preferably in a Biologics company
- Experience of microbiology testing- endotoxin and bioburden testing experience preferred
- Demonstrated understanding of continuous quality/process improvement tools (As defined by the site, e.g. DMIAC, Lean QA, 5S etc)
- Ability to work cross-functional between teams and departments
To learn more about this role apply online or call Helena Boyle on +353 1 6321870 or +353873360953 for a confidential discussion.