QA Specialist (Oligonucleotides/VLPs)

Build our future together:

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking 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.

When & where:

• Location: East Greenbush, New York, United States

• Work schedule: Monday-Friday, 8am-4:30pm

Discover your role:

• 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 requires:

• Bachelor’s degree, or equivalent combination of education and experience, and the following amount of relevant work experience for each level:

  • Associate Specialist – 0-2 years

  • Specialist - 2+ years

  • Senior Specialist - 5+ years

  • Level will be determined based on experience

• Having an understanding of VLP or si-RNA manufacturing operations

• Organization skills and attention to detail

• Ability prioritize multiple assignments and changing priorities

• Ability to learn and utilize computerized systems for daily performance of tasks

#REGNQA

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 - $128,700.00