Microbiology Analyst required for Biotech manufacturing facility in Ringaskiddy. This is a 2 cycle shift role.
Preferred testing experiences includes : Bioburden, Endotoxin, Sterility Testing, Microbial Identification using genetic methods.
- Performing a wide variety of microbiology, chemistry or biochemistry testing to support utilities, raw material, in process, bulk and drug product release.
- Rapid turnaround of samples to meet manufacturing needs.
- Performing data review and approval.
- Providing support and advice to manufacturing on QC related topics.
- Initiating and leading investigations where required.
- Initiates and completes, CAPAs and Change Controls in accordance with site procedure
- Writes new and updates current procedures on electronic documentation system.
- Presents technical analytical data clearly and concisely data to customers, i.e., internal investigations and regulatory inspectors etc.
- Proactively identifies and implements lab process improvements.
- Supports lean initiatives in the area of lab operations, i.e. standard work, level loading, test method execution, documentation updates and equipment qualification etc.
- Third-level qualification essential (Minimum: Primary degree in a science discipline).
- Preferred testing experiences includes : Bioburden, Endotoxin, Sterility Testing, Microbial Identification using genetic methods.
- Min 2 years experience within the Pharmaceutical Industry
- Knowledgeable of FDA/EMEA regulatory requirements applicable to pharmaceuticals and aseptic products.
- Experience with electronic systems such as LIMS, Electronic Lab notebooks, Empower, Trackwise preferred.
If you are interested, please contact Julieann in Morgan Mckinley. Email firstname.lastname@example.org
Morgan McKinley is acting as an Employment Agency in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.