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Regeneron is currently looking for a QC (Quality Control) Lab Operations Specialist. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. This position develops strategic plans related to change controls, maintains compliance records, and document workflows. They’re responsible for supporting Quality Control laboratories with change control, investigations, method changes and document workflows.

As a QC Lab Operations Specialist, a typical day might include the following:

+ Assess sophisticated change controls to evaluate if proposal satisfies company standards

+ Review, edit, and revise controlled documentation in accordance with cGMP standards

+ Ensures that all activities related to the investigation and resolutions of non-conformities are performed in a timely manner and in compliance with Regeneron procedures and regulatory requirements.

+ Coordinate and/or lead cross-functional meetings with multiple departments to drive change control implementation

+ Provide advice and mentorship to cross-functional teams to enable successful and GMP compliant change controls

+ Independently monitor and progress multiple projects concurrently – identifying, addressing, and/or raising potential obstacles in a timely manner

+ Present business critical and regulatory impactful change controls to senior leadership

+ Document all training

+ Assist with the training of new employees

+ Collaborates with internal and external teams to harmonize operations and ensure consistency within quality control laboratories.

+ Serves as Subject Matter Expert (SME) for laboratory operations.

This role might be for you if you :

+ Have strong technical writing and interpersonal communication skills.

+ Can manage multiple assignments and changing priorities through robust organizational, planning, and project management skills.

+ Can work independently or part of a cross-functional team.

+ Have experience navigating a controlled quality system.

To be considered for the QC Lab Operations Specialist you must be willing and able to work Monday-Friday, 8am-4:30pm. You must have a BS/BA in life sciences or equivalent combination of education and experience. For various levels you must have the following:

+ Assoc QC Lab Operations Specialist: Requires a BS/BA in a scientific field or equivalent combination of education and experience

+ QC Lab Operations Specialist: 2+ years of related experience or equivalent combination of education and experience.

+ Sr QC Lab Operations Specialist: 5+ years of related experience or equivalent combination of education and experience.

Level is determined based on qualifications relevant to the role.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.

Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.

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 (annually)

$59,700.00 - $108,400.00