Quality Control Micro Analyst- Validation

Rensselaer, NY, United States
Oct 13, 2020
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
We are currently looking to fill a Quality Control Micro Analyst focused in method validation with a 1st shift, Monday-Friday, 8am-4:30pm schedule. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our Microbiology Analysts perform validation testing for the bioburden and endotoxin assays. pH testing is also performed as part of the Endotoxin validation. This position will be responsible for development and troubleshooting of Microbiological assays utilized by the microbiology operations team. This is a great opportunity to gain a deeper understanding of microbiological assays while working on molecules that help improve patient's lives.

As a Quality Control Micro Analyst, a typical day might include the following:
• Perform bioburden and endotoxin validation
• Plate reads and verification
• Write summary reports for bioburden and endotoxin validation
• Performing studies such as low endotoxin recovery studies
• Working on Change Controls to implement new validated methods
• Working cross-functionally with other departments to support provide method validation support

This role might be for you if:
• Enjoy working in a fast-paced environment and you have the innate ability to balance multiple projects, prioritize them and execute them independently, while excelling at keeping all impacted parties well advised
• Can take on new and sometimes ambiguous challenges and learn quickly
• Are able to work in a team environment but can also take ownership of large technical reports and projects
• Develop and drive scientific and/or business-related improvement ideas
• Enjoy troubleshooting assays that show interference
• Have working knowledge of Microsoft Suite (Word, Excel, Powerpoint) and Softmax
• Understand working with statistical software such as JMP
• Enjoy developing novel assays with little initial guidance
• Have testing experience in Bioburden and Endotoxin techniques
• Have experience with developing and troubleshooting potency assays for testing in a GMP environment

To be considered for the Quality Control Micro Analyst position you must be willing and able to work 1st shift, Monday-Friday, 8am-4:30pm. You must have a BS/BA in Life Sciences of equivalent and 2+ years of related experience. Experience with either endotoxin or bioburden testing required. Level is determined based on qualifications relevant to the role. Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.