Change Control Specialist (Biotechnology)

Location: Rensselaer, New York, United States. Onsite Monday-Friday schedule, 8:00am-4:30pm.

Company

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

What you will do

• Develop strategic plans for change control initiatives, CAPAs, and process improvements supporting manufacturing operations.
• Assess proposed changes, including scope, impact, risk, and regulatory implications.
• Prepare, review, edit, and revise controlled documentation in accordance with cGMP standards.
• Coordinate and lead cross-functional meetings to drive change control implementation.
• Monitor multiple projects, address obstacles, and present business-critical and regulatory-impactful changes to senior leadership.
• Document training and assist with onboarding new employees.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, or a related field, or an equivalent combination of education and experience.
• Relevant experience: 0-2+ years for Associate level, 2+ years for Specialist level, or 5+ years for Senior level.
• Experience supporting change control, corrective and preventive actions, or process improvements in manufacturing operations.
• Ability to work with controlled documentation and cGMP requirements.
• Ability to work onsite in Rensselaer, New York, Monday-Friday from 8:00am to 4:30pm.

Culture & Benefits

• Inclusive workplace with equal employment opportunity and reasonable accommodation support.
• Competitive total rewards package that may include annual incentives, equity awards, retirement benefits, 401(k) matching, insurance, wellness programs, paid time off, and family support benefits.
• Background checks may be conducted to verify identity, right to work, and educational qualifications.