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QCAT Analyst (Microbiology)

Quality & Laboratory
Cork
Deirdre Duboy
Temporary
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Job Reference: JO-2006-65237_1592308927

Summary:

Key Responsibilities:


· Develop, optimize, validate and troubleshoot microbiological test methods


· Prepare protocols, summaries, and reports-often for direct submission to pharmaceutical regulatory agencies


· Perform review of QC raw data and trend results


· Microbiological testing performed by the lab incl: endotoxin, bioburden, sterility, rapid methods etc


· Testing of in-process, bulk drug substance, finished product, raw materials, packaging


· Prepare protocols, summaries, and reports-often for direct submission to pharmaceutical regulatory agencies


· Draft QC SOPs


· Act as technical resource (SME) and train other analysts in areas of expertise


· Evaluate results against defined acceptance criteria


· Conduct and document laboratory investigations to completion


· Maintain the laboratory in an inspection-ready state


· Interact directly with regulatory agency inspectors during audits



Key Requirements:


· B.S. in a scientific discipline


· 3+ years working in a GMP lab


· Bioburden experience


· Excellent verbal and written communication skills



Preferred requirements:


· Pharmaceutical experience


· Sterility and endotoxin


· Validation protocols


· Training of staff members



Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.


Fastnet - The Talent Group
'Not Just Placers.........Partners'


The Life Science Specialists


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Talent Consultant:
Deirdre Duboy
Deirdre Duboy
Talent Consultant
Quality & Laboratory
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