Regeneron QC Analyst

6 days ago


Limerick, Limerick, Ireland Regeneron Ireland DAC Full time
Job Description:
Regeneron Ireland DAC is seeking a highly skilled Quality Assurance Microbiologist to join our team. As a Quality Assurance Microbiologist, you will play a critical role in ensuring the microbiological quality of our products and manufacturing processes. This is a challenging and rewarding opportunity for an experienced microbiologist to contribute to the development of life-changing medicines.

Key Responsibilities:
* Conduct microbiological testing and analysis to ensure cGMP compliance in our manufacturing facility
* Perform environmental monitoring and sample analysis to assess the microbiological quality of products, manufacturing equipment, and process areas
* Collaborate with manufacturing personnel to identify microbiological root causes and provide technical advice as needed
* Develop and maintain standard operating procedures (SOPs) for microbiological testing and analysis
* Participate in microbiological validations for drug substances, in-process controls, buffers, and clean utilities qualification programs
* Conduct laboratory investigations and generate reports in response to invalid assays, deviations, OOS/OOT
* Communicate analytical data reports clearly and concisely to management

Requirements:
* BS/BA or equivalent experience in Microbiology or related field
* 2+ years of validated experience, or equivalent combination of education and experience
* Strong trouble-shooting and problem-solving skills
* Strong attention to detail and excellent written and oral skills

Benefits:
At Regeneron Ireland DAC, we offer a comprehensive benefits package that includes health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.
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