Quality Compliance Specialist (Quality Risk Management)

Location: East Greenbush, New York, United States. Onsite schedule: Monday–Friday, 8:00 a.m.–4:30 p.m.

Salary: $62,355–$128,700 annually

Company

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

What you will do

• Provide technical expertise in quality risk management to Quality Assurance, Quality Control, Manufacturing, Medical Device, and Facilities teams.
• Facilitate data-driven risk assessments and reviews using FMEA, RBIA, REM, HACCP, and other appropriate methodologies.
• Guide teams through risk identification, analysis, mitigation, control, and residual-risk evaluation.
• Prepare and revise QRM documentation and contribute to contamination-control and aseptic-processing risk assessments for fill-finish operations.
• Support regulatory, customer, and internal audits and inspections while coaching colleagues on QRM principles.
• Track risk-management metrics and identify opportunities for continuous improvement.

Requirements

• Bachelor’s degree in Biological Sciences, Chemistry, Biochemistry, Engineering, or a related field, or an equivalent combination of education and experience.
• Relevant experience: 0+ years for Associate Specialist, 2+ years for Specialist, or 5+ years for Senior Specialist; level depends on experience.
• Understanding of quality risk management principles and the ability to make sound risk-based decisions from complex technical and systems information.
• Strong collaboration, influence, communication, and cross-functional facilitation skills.
• Proficiency with Microsoft Word, Excel, and PowerPoint.

Nice to have

• Experience with Veeva.

Culture & Benefits

• Inclusive workplace with equal employment opportunity.
• Benefits may include bonuses or incentive plans, equity awards, retirement benefits, health and wellness programs, insurance, paid time off, and family support benefits.
• Background checks may verify identity, right to work, and educational qualifications where required by law.