We are currently looking to fill a Quality Assurance Specialist (Gene Therapy) 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. This position is a desk-based compliance & quality position.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 adeno-associated viruses (AAV), virus-like particles (VLPs), 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.), activities may be on the floor or at a desk
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 AAV, VLP, si-RINA or biologics 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:
QA Associate – 0-2+ years
Associate QA Specialist – 2+ years
QA Specialist – 4+ years
May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.#REGNQA#REGNECDoes 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)$23.89 - $106,300.00