The QA Commercial Packaging team is hiring! The QA Specialist performs activities in support of dispositioning product while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents. This position is in Commercial & Emergency Use Authorization (EUA) Packaging Operations with Contract Manufacturing Operations (CMOs).
In this role, a typical day may include:
Perform routine activities associated with disposition of product lots (e.g. batch documentation and ancillary documentation review and approval, etc.)
Represent Quality Assurance and Regeneron in interactions with CMOs, cross functional teams within Regeneron, and other external parties
Provide consultation or advice in alignment with QA procedures and policies
Activities are at desk with potential travel
Review, edit, or approve Regeneron controlled documents
Represent Quality Assurance in support of Deviations, Change Controls, Corrective and Preventative Actions, etc., including active participation in investigation, evaluation, and problem resolution
Train and/or mentor junior employees, including providing insights and education on processes and procedures
Perform activities associated with the commercialization of new products and packaging process improvements (e.g. batch documentation and ancillary documentation review and approval, etc.)
Continually evaluating Regeneron processes and procedures with an eye toward continuous improvement
This role may be a fit for you if you have:
Understanding of biologics manufacturing operations and packaging operations is helpful
Good organizational skills and attention to detail
Requires good written, verbal, and interpersonal communication skills and the ability to effectively interact cross functionally
Ability to handle multiple assignments and changing priorities
Ability to learn and use computerized systems for daily performance of tasks
Ability to prioritize, lead multiple tasks, and meet deadlines
Ability to work a multifaceted schedule including off shift and weekends
To be considered for this role you must hold a BS/BA in a scientific discipline and the following years of experience for each level:
Associate QA Specialist: 2+ years
QA Specialist: 4+ years
Sr. Specialist: 6+ years
May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.
#REGNQA
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 comprehensive benefits including health and wellness programs, fitness centers and 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. 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.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)
$57,100.00 - $124,300.00