Quality Control Analyst (Microbiology)

Regeneron Pharmaceuticals•Rensselaer, IN

1d•$25 - $39•Onsite

About The Position

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.

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.

Nice To Haves

Prior GMP experience in Microbiology related to drug substance or drug product manufacturing is preferred.

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.