Senior Quality Assurance Specialist

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

Benefits offered by this job

Annual bonuses

Equity awards

Pension or retirement benefits

401(k) company match

Health and wellness programs

Paid time off

Job summary

Regeneron Pharmaceuticals, Inc. in East Greenbush, NY, is seeking a Sr. Quality Assurance Specialist to provide leadership-level quality oversight for Drug Product Manufacturing.

This role partners with project managers to ensure quality objectives are achieved across formulation, fill/finish, assembly, packaging and labeling. The position requires a BS/BA in Life Sciences or related field with several years of QA experience; responsibilities include audits, regulatory readiness, and

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; Specialist: 4+ years.

Responsibilities

• Provides operational support including formulation, fill/finish, assembly, packaging and labeling activities.
• Interfaces with Manufacturing Project Managers for quality-related issues at suppliers or internally at the fill/finish site.
• Resolves problems, identifies trends and drives system improvements across multiple programs and sites.
• Ensures compliance with internal procedures and regulatory expectations by cross-site collaboration.
• Supports audit and inspection readiness across Quality Assurance, including as needed in audits and inspections.
• Communicates and tracks compliance and regulatory requirements across departments.
• Prepares and completes action plans; implements productivity, quality and customer-service standards.
• Implements change within GMP guidelines.
• Oversees multiple projects as needed.

Skills

Quality oversight

GMP compliance

Education

BS/BA in Life Sciences, Engineering or related field

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.

When & Where:

Location: East Greenbush, New York, United States

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

Discover your role:

• 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

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.

Benefits & Compensation:

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.

Salary range (annually)
$78,700.00 - $128,700.00

• 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
• Family support benefits

On‑site Requirements:

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.

Background Checks:

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.

If you have any questions, please speak with your recruiter.