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About the Role

Regeneron is seeking Investigation Specialists to join our internal fill finish and global manufacturing teams. These positions perform compliance-related tasks vital to completing investigations and implementing robust corrective actions for manufacturing operations, contributing to a fast-growing, science-driven organization.

Responsibilities

• Independently investigate non-conformances and prevent reoccurrences in support of manufacturing operations.
• Prepare investigation reports including recommendations for medium/high severity non-conformances.
• Analyze and evaluate information captured through investigations, summarizing trends in reports.
• Review completed batch records and logbooks in accordance with cGMP standards.
• Review, edit, and revise controlled documents (batch records, logbooks, SOPs, etc.) to ensure compliance.
• Monitor production processes to acquire vital data and track efficiency of changes.
• Participate in and/or lead cross-functional study teams to support investigations.
• Gather, trend, and analyze process-related data to drive consistency and timeliness.

Requirements

• B.S. in life sciences, engineering, or related field; may substitute proven experience for education requirement.
• Associate Investigation Specialist: 0-2+ years of experience.
• Investigation Specialist: 2+ years of experience.
• Senior Investigation Specialist: 5+ years of experience.
• Level will be determined based on experience.

Location

• Rensselaer, New York, United States

Work Type

• On-site

Experience Level

• Associate Investigation Specialist: 0-2+ years
• Investigation Specialist: 2+ years
• Senior Investigation Specialist: 5+ years

Education Level

• B.S. in life sciences, engineering or related field

Salary/Compensations

• $62,355.00 - $110,000.00

Benefits

• 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

About the Company

• Regeneron uses science and innovation to develop life-changing medicines for people with serious diseases.
• We are committed to building a workplace with an inclusive culture.
• 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.
• We will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.