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 our 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

• 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.
• Technical writing assignments including but not limited to SOPs, protocols, reports, trend reports, risk assessments, laboratory investigations, change controls.
• Environmental monitoring of controlled environments, personnel and clean utilities.
• Training of employees.
• Peer review of data.
• Maintaining laboratory supplies, media, and reagents.
• Enjoy working in a fast-paced environment and you have the innate ability to balance multiple priorities, prioritize them, and execute.
• Develop and drive scientific and/or business-related improvement ideas.
• Have working knowledge of 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, and a minimum of 12-18+ months of related experience.
• You must be able to work 2nd shift, Wednesday - Saturday, 1:00pm- 11:30pm.
• Occasional off shift/weekend work/holiday coverage needed.

Qualifications

• Prior GMP experience in Microbiology related to drug substance or drug product manufacturing is preferred.
• Level is determined based on qualifications relevant to the role.

Pay & Schedule

• Schedule: Wednesday - Saturday, 1:00pm - 11:30pm (2nd shift)
• Hourly range: $24.76 - $38.70
• Occasional off shift/weekend work/holiday coverage needed.