Quality Assurance Specialist (Batch Record & Disposition) (Biotech)

Location: East Greenbush, New York, United States. Onsite, Monday–Friday, 8:00 a.m.–4:30 p.m.; 10% domestic travel.

Salary: $62,355–$110,000 annually.

Company

Regeneron is a science-driven biotechnology company developing medicines for people with serious diseases.

What you will do

• Perform and lead QA activities supporting product disposition, including document review, disposition package preparation, and Certificate of Analysis review.
• Represent QA in deviations, change controls, CAPAs, investigations, evaluations, and problem resolution.
• Review and approve investigations involving raw materials, products, laboratories, facilities, and materials.
• Review, edit, and approve controlled documents in compliance with QA policies, cGMPs, SOPs, and standard requirements.
• Represent the IOPS organization with external partners, communicate QA procedures, and address issues at external sites.
• Provide QA consultation, mentor junior employees, and identify opportunities for continuous process improvement.

Requirements

• Bachelor’s degree in life sciences or a related field; proven experience may substitute for the education requirement.
• Associate QA Specialist level: 2+ years of experience.
• QA Specialist level: 4+ years of experience.
• Experience level will determine the final position level.
• Ability to work onsite in East Greenbush, New York, during Monday–Friday business hours.

Culture & Benefits

• Work in a fast-growing, science-driven organization focused on improving patient outcomes.
• Inclusive workplace and equal employment opportunity environment.
• Benefits may include annual bonuses or incentive plans, equity awards, retirement benefits, 401(k) matching, health and wellness programs, insurance, paid time off, and family support benefits.
• Reasonable accommodations are available during the recruitment process where required.