Quality Control Analyst (Microbiology)

About the role

Regeneron is currently looking for a 2nd shift Quality Control (QC) Microbiology Analyst. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including approved therapeutic proteins and those involved in clinical studies. Quality Control Microbiology analysts perform a variety of microbiological responsibilities including clean room and utility monitoring as well as raw material, in-process, and product testing in accordance with Standard Operating Procedures (SOPs) and cGMP/FDA regulation.

Responsibilities

• Perform microbiological testing and analysis (bioburden testing, endotoxin content testing, plate enumeration, growth promotion, etc.) on a variety of sample types.
• Perform biological indicator testing used in the validation of manufacturing equipment.
• Complete technical writing assignments including SOPs, protocols, reports, trend reports, risk assessments, laboratory investigations, and change controls.
• Conduct environmental monitoring of controlled environments, personnel, and clean utilities.
• Train employees.
• Perform peer review of data.
• Maintain laboratory supplies, media, and reagents.
• Balance multiple priorities and execute tasks efficiently in a fast-paced environment.
• Develop and drive scientific and/or business-related improvement ideas.
• Use Microsoft Suite (Word, Excel, PowerPoint), Laboratory Information Management System (LIMS), Deviation Management Systems, and Learning Management Systems.

Requirements

• BS/BA in Life Sciences or related field.
• Minimum of 12–18+ months of related experience.
• Ability to work 2nd shift, Wednesday–Saturday, 1:00 pm–11:30 pm.
• Occasional off-shift, weekend work, and holiday coverage required.
• Prior GMP experience in microbiology related to drug substance or drug product manufacturing is preferred.