Senior Quality Assurance Specialist

Regeneron Pharmaceuticals•Rensselaer, NY
•$78,700 - $128,700•Onsite

About The Position

Regeneron is seeking a Senior Quality Assurance Specialist to support internal Drug Product Manufacturing. The role provides leadership-level quality oversight and contributes to quality objectives through planning and evaluating project activities in a fast-growing, science-driven organization. The position is based in East Greenbush, New York, and follows a Monday–Friday, 8:00 a.m.–4:30 p.m. schedule. The role is expected to be performed on-site; candidates should confirm specific on-site expectations with the recruiter and hiring manager.

Requirements

  • Bachelor of Science or Bachelor of Arts in Life Sciences, Engineering, or a related field, or an equivalent combination of education and experience.
  • At least 6 years of proven experience for the Senior Specialist level.

Responsibilities

  • Provide operational support for formulation, fill/finish, assembly, packaging, and labeling activities.
  • Act as the quality interface with Manufacturing Project Managers or Internal Project Managers regarding quality issues at suppliers or internally at the fill/finish site.
  • Resolve problems, identify trends, and determine system improvements across multiple programs and sites.
  • Ensure compliance with internal procedures and regulatory expectations by proactively working across the site.
  • Support audit and inspection readiness across Quality Assurance, including assisting with audits and inspections as needed and tracking readiness.
  • Communicate and track compliance and regulatory requirements across departments.
  • Prepare and complete action plans and implement productivity, quality, and customer-service standards.
  • Implement changes, when necessary, within the guidelines of GMP manufacturing operations.
  • Support primary and secondary components and packaging operations and suppliers as needed.
  • Oversee multiple projects as needed.

Benefits

  • Annual bonuses or other incentive plans may be offered, depending on country and role.
  • Equity awards may be offered, depending on country and role.
  • Pension or retirement benefits may be offered, depending on country and role.
  • 401(k) company match may be offered, depending on country and role.
  • Health and wellness programs may be offered, depending on country and role.
  • Fitness centers may be available, depending on country and role.
  • Insurance benefits may include medical, dental, vision, life, and disability coverage, depending on country and role.
  • Paid time off may be offered, depending on country and role.
  • Family support benefits may be offered, depending on country and role.
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