Quality Control Analyst - Raw Materials

Regeneron is looking for a Quality Control (QC) Analyst for our QC Raw Materials laboratory with a focus on data review working Sunday Thursday on a 2nd shift schedule (2pm 10:30pm). Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. The QC Raw Materials laboratory performs chemical testing of Raw Materials used in the manufacturing process using a wide variety of manual and instrument testing procedures. This role will focus on reviewing and approving laboratory test data and results to ensure all testing and activities are in compliance with current Good Manufacturing Practices (cGMPs) and Regenerons internal procedures and policies. This role will also include opportunities to train on and perform laboratory tests and analyze data.
As a QC Analyst with a focus on data review, a typical day might include the following:
Perform detailed data review for analytical test results generated internally and by external contract labs for compliance with cGMPs, internal procedures and policies, and raw material specifications. Review both electronic and paper-based records in the laboratory environment.
Perform Raw material testing
Train other employees on lab / review activities
Perform laboratory investigations
Write / revise laboratory related documents (e.g. SOPs, SPECs)
Maintain laboratory supplies and documentation
Ensure continuous compliance to cGMP requirements and data integrity (e.g. Laboratory cleanliness, equipment within calibration, proper documentation, no expired reagents/standards)
May be responsible for special projects (e.g. process improvements, execution of test plans, assist with transfer of methods)
This role might be for you if you:
Have experience reviewing laboratory data

Are organized and have meticulous attention to detail
Are able to work in an ever-changing environment
Have experience working in a laboratory environment, especially with raw material chemistry testing procedures and instrumentation (e.g. HPLC, UPLC, Raman spectroscopy / FTIR, wet chemistry, auto-titrations)
Have experience with compendia testing procedures (USP, Ph.Eur, JP, BP)
Are able to learn and utilize computerized systems for daily performance of tasks
Possess excellent verbal and written communication skills
Can work well independently and as part of a team
Have a drive for continuous improvement

To be considered for the QC Analyst role you must be willing and able to work 2nd shift, Sunday - Thursday, 2:00pm- 10:30pm. . Various levels require the following: QC Analyst: BS/BA in Life Sciences, or related field, and a minimum of 12-18+ months of related experience; or an equivalent combination of education and experience Sr. QC Analyst I: BS/BA in Life Sciences, or related field, and 4+ years of experience; or an equivalent combination of education and experience. Sr. QC Analyst II: BS/BA in Life Sciences, or related field, and 6+ years of experience; or an equivalent combination of education and experience.

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, annual bonuses, and paid time off for eligible 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 parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (hourly)