About the role
We are currently looking to fill a Quality Assurance Specialist (Oligonucleotides/Virus-like particles (VLPs)) position. This position performs activities supporting dispositioning product and/or raw materials while ensuring compliance with Quality Assurance policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents.
In this role, a typical day might include the following:
Reviewing and approving batch records from Contract Manufacturing Organizations (CMO) manufacturing bulk drug substance including VLPs and small interfering RNAs (si-RNA)
Representing Quality Assurance in support of sophisticated Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution
Providing consultation or advice in alignment with QA policies
Performing activities associated with disposition of raw materials and product (e.g. receipt, inspection, document review, shipping, etc.)
Reviewing, editing, or approving Regeneron controlled documents
Reviewing and approving of investigations associated with raw materials, product, laboratory, facilities, and materials
Performing status labeling of raw materials and product
Continually evaluating Regeneron processes and procedures with an eye toward continuous improvement
This role may be for you if you:
Excel in a quality driven organization
Have an understanding of VLP or si-RNA manufacturing operations
Are organized and have an attention to detail
Can prioritize multiple assignments and changing priorities
Are able to learn and utilize computerized systems for daily performance of tasks
To be considered for this role you must hold a Bachelor’s degree and the following amount of relevant experience for each level:
Associate QA Specialist – 2+ years
QA Specialist – 4+ years
Sr QA Specialist - 6+ years
May substitute proven experience for education requirement. 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 are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.
Salary Range (annually)
$62,355.00 - $128,700.00Skills & Tags
Aplyr's read
Regeneron Pharmaceuticals is a biotechnology leader focused on innovative medicines for serious diseases, attracting talent in scientific, regulatory, and commercial roles.
What's promising
- •Regeneron is at the forefront of biotechnology with a strong pipeline of innovative medicines.
- •The company offers diverse roles across scientific, regulatory, and commercial functions, indicating robust growth.
- •Regeneron's commitment to R&D is evident in its substantial investment in cutting-edge technologies.
What to watch
- •The competitive biotechnology field requires constant innovation, posing sustainability challenges.
- •Regeneron's success heavily depends on regulatory approvals, which can be unpredictable.
- •The company faces significant competition from other biotech firms in drug development.
Why Regeneron
- •Regeneron has a distinctive focus on antibody-based medicines, setting it apart in the biotech industry.
- •The company is renowned for its proprietary VelociSuite technologies, enhancing drug discovery.
- •Regeneron's collaborative culture fosters innovation and cross-disciplinary teamwork in drug development.
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About Regeneron
Regeneron Pharmaceuticals is a leading biotechnology company that discovers, develops, and commercializes innovative medicines for serious diseases.