Quality Assurance Specialist, MES

About the role

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. This position will provide QA input and oversight to the development and maintenance of Manufacturing Execution System (MES) business processes, including documentation requirements and overall design of internal Drug Product (DP) manufacturing records and supporting documentation.

Location: Rensselaer, New York, United States, with a work model of Monday-Friday, 8am-4:30pm.

Responsibilities

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

Requirements

• Requires B.S in life sciences or related field; may substitute proven experience for education requirement
• Associate Quality Assurance Specialist: 2+ years of experience
• Quality Assurance Specialist: 4+ years of experience
• Level will be determined based on experience

Benefits

• Student loan paydown program & tuition reimbursement
• Family care benefits
• Relocation assistance
• Inclusion, culture and well-being programs (including physical & mental health)

Pay

Salary Range (annually) $62,355.00 - $110,000.00

Schedule

Monday-Friday, 8am-4:30pm