Senior Quality Assurance Validation Specialist (Pharmaceuticals)

Location: Rensselaer, New York, United States; onsite, Monday–Friday, 8:00am–4:30pm

Salary: $67,400–$128,700 annually

Company

hirify.global develops medicines for people with serious diseases through science and innovation.

What you will do

• Generate, execute, review, and approve qualification and validation protocols, reports, and supporting data.
• Analyze test results against predefined acceptance criteria and investigate deviations, problems, and corrective actions.
• Review and approve change controls, SOPs, deviation investigations, and quality documentation.
• Coordinate validation activities with internal departments and external contractors or vendors.
• Execute transport studies, temperature mapping, packaging qualifications, and small-parcel and palletized-load testing.
• Program instrumentation and sensors to capture vibration, shock, humidity, and pressure data for packaging design and root-cause analysis.

Requirements

• Bachelor’s degree in life sciences or a related field, or proven equivalent experience.
• 6+ years of experience for the Senior QA Validation Specialist level; level is determined by experience.
• Experience with equipment, systems, process, packaging, or environmental qualification and validation.
• Knowledge of regulatory requirements, SOPs, specifications, and acceptance criteria.
• Ability to wear full cleanroom attire and remove jewelry, makeup, and nail adornments during gowning.
• Ability to work onsite in Rensselaer, New York, Monday–Friday, 8:00am–4:30pm.

Culture & Benefits

• Student loan paydown program and tuition reimbursement.
• Family care benefits.
• Relocation assistance.
• Inclusion, culture, and well-being programs supporting physical and mental health.
• Comprehensive rewards package may include bonuses, equity awards, retirement benefits, insurance, and paid time off.