Principal Quality Assurance Reviewer (Biotech)

Location: Rensselaer, New York, United States; Monday–Friday, 8:00 a.m.–4:30 p.m.; onsite expectations apply.

Salary: $92,200–$176,000 annually

Company

hirify.global is a biotechnology company that discovers, develops, and commercializes medicines for serious diseases.

What you will do

• Review and approve investigations into non-conformances, laboratory OOS/OOT results, and supplier corrective action requests.
• Coach investigation teams and evaluate findings, recommendations, and proposed actions to prevent recurrence.
• Review primary data sources and quality-system information to verify investigative conclusions against cGMP standards.
• Monitor manufacturing processes and quality data, identifying trends and tracking the effectiveness of changes.
• Present quality recommendations to management and coordinate or lead cross-functional meetings and study teams.
• Train employees on investigation processes and techniques.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, or a related field, or an equivalent combination of education and experience.
• 8+ years of relevant experience for Principal QA Specialist level; 10+ years for Staff QA Specialist level. Final level will be determined by experience.
• Experience with sterile drug product manufacturing, fill-finish operations, and/or quality-control testing.
• Knowledge of cGMP standards and quality investigation practices.

Culture & Benefits

• Science-driven environment focused on developing medicines for serious diseases.
• Comprehensive rewards may include annual incentives, equity awards, retirement benefits, 401(k) matching, insurance, paid time off, and family support benefits.
• Inclusive workplace with reasonable accommodation available during the recruitment process where required.