Senior Qc Micro Analyst

11 hours ago


Limerick, Limerick, Ireland Regeneron Ireland Dac Full time

Within this role you will perform testing to ensure cGMP compliance in the manufacturing facility.
Responsible for assessing the microbiological quality of products, manufacturing equipment, manufacturing process areas, and facility utilities.
Note, this is a shift based role (12/7 - extended days) As a Senior QC Micro Analyst a typical day might include, but is not limited to, the following: Entering laboratory clean-rooms to collect and log samples for microbial analysis.
Performing bioburden and endotoxin sample analysis in line with standard operating procedures (SOPs).
Performing sample analysis for microbial identification.
Performing environmental monitoring, including surface, settling, and viable and non-viable particulate air monitoring of aseptic operations and controlled areas.
Performing acceptance testing of commercially prepared microbiological culture media.
Autoclaving microbiological media and laboratory waste as needed.
Ensuring all work is carried out in compliance with regulatory standards, company policies, and SOPs.
Completing test records on time and peer reviewing data from other analysts for accuracy and completeness.
Assisting in the design and setup of the QC microbiology laboratory and selecting, implementing, and calibrating laboratory instruments.
Participating in microbiological validations for drug substances, in-process controls, buffers, and clean utilities qualification programs.
Assisting manufacturing personnel in identifying microbiological root causes and providing technical advice as needed.
Participating in the



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