Assoc QC Micro Analyst

• 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 transfer of methodologies from other test facilities.
• Maintaining laboratory reagents, media, and supplies.
• Conducting laboratory investigations and generating reports in response to invalid assays, deviations, OOS/OOT.
• Initiating and completing CAPAs and change controls in adherence with site procedures.
• Communicating analytical data reports clearly and concisely to management.
• Identifying and implementing lab process improvements and lean initiatives.

• You have a consistent record to work independently or as part of a team
• You possess strong trouble-shooting and problem solving skills
• You have strong attention to detail & excellent written and oral skills

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, an