Senior Quality Assurance Specialist

Regeneron Pharmaceuticals, Inc (USA); United States; On-site; USD 79,000 - 129,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc (USA) is seeking a Sr. Quality Assurance Specialist to support Drug Product Manufacturing. You will provide leadership-level quality oversight and help achieve quality objectives in a fast-growing, science-driven environment.

Location: East Greenbush, New York. Work model: Monday-Friday, 8am-4:30pm. Essential duties include supporting formulation, fill/finish, packaging and labeling, ensuring GMP compliance and readiness for audits.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Quality oversight

GMP compliance

Regulatory readiness

Education

BS/BA in Life Sciences or Engineering

Job description

Build the future with us: At Regeneron, we apply science and innovation to create life-changing medicines for people living with serious diseases. We are looking for a Sr. Quality Assurance Specialist to support our Drug Product Manufacturing (Internally). In this role, you will be a partner by providing leadership-level quality oversight and responsible for accomplishing quality objectives by planning and evaluating project activities. This position lets you contribute to a fast-growing, science-driven organization that makes a meaningful difference for patients worldwide.

Location: East Greenbush, New York, United States

Work model: Monday-Friday, 8am-4:30pm

Discover your role:

Essential Duties and Responsibilities include, but are not limited to, the following:

• 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.

Salary Range (annually)

$78,700.00 - $128,700.00

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases.

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.

Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.

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.