Senior Quality Assurance Specialist, Material Supplier

Regeneron; United States; Sur place; USD 67 000 - 129 000; Plein temps

Résumé du poste

Regeneron Pharmaceuticals, Inc. is seeking a Senior Quality Assurance Specialist, Material Supplier to lead end-to-end management of supplier-initiated changes to GMP materials and components, safeguarding product quality and compliance.

This on-site role in Rensselaer, NY offers a Monday–Friday schedule with a total rewards package. You will coordinate supplier change notifications globally, support deviations and CAPAs, and maintain controlled documents.

Qualifications

• Bachelor's degree in scientific subject area or related field; relevant years of experience per level: Specialist: 2+ years; Sr. Specialist: 5+ years.

Responsabilités

• Reviews and coordinates Supplier Change Notifications across global suppliers, including intake, triage, risk assessment, cross functional impact evaluation, communication, and closure.
• Supports the resolution of internal and external deviations
• Maintain and update-controlled documents related to supplier change notification.
• Supports execution of Corrective/Preventative Actions (CAPAs) arising from supplier changes, audits, or process gaps.
• Gathers, evaluates and provides information/documentation to support regulatory inspections and inquiries, as well as partner and internal audits.
• Performs continuous improvement of the Material & Supplier Quality program with a focus on SCN workflow efficiency, cycle time reduction, and right first time.
• Manages and tracks projects to ensure milestones are achieved while complying with established timelines.
• Experience partnering with suppliers of GMP materials/components preferred.
• Previous quality experience in a GMP environment.

Connaissances

Supplier Change Notifications

GMP

Quality Assurance

Formation

Bachelor's degree in scientific subject area

Description du poste

Build our future together:

Our Material & Supplier Quality Assurance team is hiring a Senior Quality Assurance Specialist, Material Supplier to lead end-to-end management of supplier-initiated changes to GMP materials and components, safeguarding product quality, compliance, and supply. This role provides global coordination for supplier change notifications.

When & where:

Location: Rensselaer, New York, United States

Work Model: Monday - Friday, 8:00 AM to 4:30 PM

Discover your role:

• Reviews and coordinates Supplier Change Notifications across global suppliers, including intake, triage, risk assessment, cross functional impact evaluation, communication, and closure.
• Supports the resolution of internal and external deviations
• Maintain and update-controlled documents related to supplier change notification.
• Supports execution of Corrective/Preventative Actions (CAPAs) arising from supplier changes, audits, or process gaps.
• Gathers, evaluates and provides information/documentation to support regulatory inspections and inquiries, as well as partner and internal audits.
• Performs continuous improvement of the Material & Supplier Quality program with a focus on SCN workflow efficiency, cycle time reduction, and right first time.
• Manages and tracks projects to ensure milestones are achieved while complying with established timelines.
• Experience partnering with suppliers of GMP materials/components preferred.
• Previous quality experience in a GMP environment.

This role requires:

Bachelor's degree in scientific subject area or related field and the following years of experience for each level:

• Specialist: 2+ years
• Sr. Specialist: 5+ years
• May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

Does this sound like you? 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 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 on‑site. Please speak with your recruiter and hiring manager for more information about on‑site 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)

$67,400.00 - $128,700.00