Senior QA Specialist, GMP & Audit Readiness

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

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