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About the Role

Regeneron is seeking a Quality Assurance (QA) Specialist- MES to join the QA Operations Batch team. This role provides QA input and oversight for the development and maintenance of Manufacturing Execution System (MES) business processes, including documentation and design of internal Drug Product manufacturing records.

Responsibilities

• Partner with DP manufacturing, MES Operations, and internal groups to establish the MES program foundation for internal DP operations.
• Collaborate with Regeneron colleagues globally to ensure consistent MES implementation and maintenance practices.
• Build and maintain QA training curriculum for QA MES specialists.
• Review and approve MES recipes, Design Specifications, SOPs, policies, work instructions, and test plans.
• Support pre-production executions.
• Provide quality oversight review/approval for MES deviations, change controls, and CAPAs.
• Assess documentation, including SOPs, SPECS, Process Transmittals, and Manufacturing Batch Records for MES impact.
• Provide end-user support for MES usage and troubleshoot QA-related problems with IT.
• Author, review, and approve SOPs and other documents to support drug product operations.
• Support audits, inspections, and investigations.
• Possess advanced problem-solving skills to address ambiguous issues and present solutions.

Requirements

• B.S. in life sciences or related field, or equivalent experience.
• 2+ years of experience for Associate Quality Assurance Specialist.
• 4+ years of experience for Quality Assurance Specialist.
• Level will be determined based on experience.

Location

• Rensselaer, New York, United States

Work Type

• On-site

Experience Level

• Associate Quality Assurance Specialist: 2+ years
• Quality Assurance Specialist: 4+ years

Education Level

• B.S. in life sciences or related field

Salary/Compensations

• $62,355.00 - $110,000.00

Benefits

• Student loan paydown program
• Tuition reimbursement
• Family care benefits
• Relocation assistance
• Inclusion, culture and well-being programs
• Physical & mental health programs
• Annual bonuses or other incentive plans
• Equity awards
• Pension or retirement benefits
• 401(k) company match
• Health and wellness programs
• Fitness centers
• Insurance benefits (medical, dental, vision, life and disability)
• Paid time off
• Family support benefits

About the Company

• Regeneron uses science and innovation to develop life-changing medicines for people with serious diseases.
• We believe we do our best work when we are together.
• Many roles are required to be performed on-site.

Equal Opportunity

• 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.