Senior Quality Assurance Specialist

Provides operational support including formulation, fill/finish, assembly, packaging and labeling activities.

Acts as an interface with Manufacturing Project Managers or Internal Project Managers for all quality related issues at the suppliers or internally at the fill/finish site.

Resolves problems, identifies trends and determines system improvements across multiple programs and sites.

Ensures compliance with internal procedures and regulatory expectations by proactively working across site.

Support audit and inspection readiness across Quality Assurance which may include assisting as needed in audits and inspections while tracking readiness.

Communicating and tracking compliance and regulatory requirements cross-departmental.

Prepares and completes action plans; implementing productivity, quality and customer-service standards.

Implements change, when necessary, within the guidelines of GMP manufacturing operations.

May support primary component and secondary components and packaging operations and suppliers.

Oversees multiple projects as needed

This Role Requires

BS/BA in Life Sciences, Engineering or related field; or equivalent combination of education and experience

Principal QA Specialist: 8+ years of proven experience

Sr Specialist: 6+ years of proven experience

Specialist: 4+ Years of proven experience

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 onsite. Please speak with your recruiter and hiring manager for more information about onsite 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)

$78,700.00 - $128,700.00