Senior QA Floor Lead – 3rd Shift (Biotech)

Regeneron Pharmaceuticals, Inc (USA); City of Rensselaer (NY); Presencial; USD 79.000 - 129.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual bonuses or incentives

Equity awards

Pension or retirement benefits

401(k) company match

Health and wellness programs

Fitness centers

Insurance benefits (medical, dental, V

Paid time off

Family support benefits

Descripción de la vacante

Regeneron Pharmaceuticals, Inc (USA) is seeking a Senior Quality Assurance Specialist to perform and lead floor activities supporting dispositioning of product and raw materials while upholding QA policies and cGMPs.

The role requires on-site presence in Rensselaer, NY with a 3rd shift schedule (Wed-Sun, 10:00 PM – 8:30 AM). Salary range is $78,700–$128,700 annually, with comprehensive benefits and growth opportunities in a leading biotech environment.

Formación

• On-floor QA role requiring compliance with cGMPs and SOPs.
• Experience with sterile drug product manufacturing, fill finish, or QC testing.
• Strong capability to review and approve investigations and controlled documents.

Responsabilidades

• Lead QA activities for deviations, change controls, and CAPAs.
• Communicate QA policies with internal and external partners.
• Train and mentor staff on QA processes and expectations.
• Provide QA guidance during events and questions on the floor.
• Disposition product and review manufacturing records and source data.
• Review and approve Regeneron controlled documents and investigations.
• Drive continuous improvement of QA processes.
• Supervise direct reports and conduct monthly performance meetings.

Conocimientos

QA on-floor presence

Deviations & CAPAs

Regulatory communication

Mentoring & training

Document review

Investigations

Continuous improvement

Educación

BS/BA in Life Sciences or Engineering

Descripción del empleo

Regeneron Pharmaceuticals, Inc (USA) is seeking a Senior Quality Assurance Specialist to perform and lead floor activities supporting dispositioning of product and raw materials while upholding QA policies and cGMPs.

The role requires on-site presence in Rensselaer, NY with a 3rd shift schedule (Wed-Sun, 10:00 PM – 8:30 AM). Salary range is $78,700–$128,700 annually, with comprehensive benefits and growth opportunities in a leading biotech environment.