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Job Description
A QC Micro Analyst is sought with 2 years' pharmaceutical industry experience to work in a leading bio-pharma company in Cork on a 2 cycle or 4 cycle shift pattern for 12 months.
**Job Description:**
* Perform 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.
* Perform data review and approval.
* Initiate and lead investigations where required.
* Initiate and complete CAPAs and Change Controls in accordance with site procedure.
* Write new and update current procedures on electronic documentation system.
* Present technical analytical data clearly and concisely to customers, i.e., internal investigations and regulatory inspectors etc.
* Support lean initiatives in the area of lab operations, i.e., standard work, level loading, test method execution, documentation updates and equipment qualification etc.
**Requirements:**
* Third-level qualification (Minimum: Primary degree in a science discipline).
* A minimum of 2 years experience within the Pharmaceutical Industry.
* Knowledgeable of FDA/EMEA regulatory requirements applicable to pharmaceuticals and aseptic products.
* Preferred experience in: Bioburden Endotoxin Sterility Testing Microbial Identification using genetic methods.
* Experience with electronic systems such as LIMS, Electronic Lab notebooks, Empower, Trackwise desired.