Quality Specialist (Pharmaceutical Quality)

Location: Hybrid role based out of the Bridgewater, New Jersey office, with remote work available most of the time and in-person collaboration as needed. Occasional domestic and international travel of up to 10% is required.

Salary: $39.00–$50.00 hourly

Company

hirify.global is a global biopharmaceutical company developing treatments for patients with serious and rare diseases.

What you will do

• Perform batch disposition activities for pipeline drug substance, drug product, and medical devices.
• Review and approve batch records, certificates of analysis, and other release documentation.
• Generate certificates of release, create lots in electronic systems, and upload required documents.
• Ensure compliance with cGMP regulations and other requirements for pharmaceutical manufacturing and product release.
• Collaborate with internal teams and external suppliers to resolve quality issues and support timely product release.
• Develop SOPs, maintain quality records, monitor QA metrics, and drive continuous improvement initiatives.

Requirements

• Bachelor’s degree in Chemistry, Life Science, or a related discipline.
• At least 3 years of experience working in a pharmaceutical company.
• Experience with pharmaceutical manufacturing processes, medical devices, analytical laboratory practices, batch record review, and product release.
• Knowledge of cGMP requirements and regulations applicable to GMP manufacturing and product release.
• Experience with an electronic document management system and strong proficiency in Microsoft Office.
• Excellent communication, project management, organization, attention to detail, accuracy, and workload management skills.

Nice to have

• Knowledge of the Veeva Quality Vault system.

Culture & Benefits

• Medical, dental, vision, and mental health coverage.
• Paid time off, fertility and family-forming benefits, caregiver support, and flexible work schedules.
• 401(k) plan with company match, annual equity awards, ESPP, and company-paid life and disability insurance.
• Learning programs, LinkedIn Learning access, workshops, mentorship, and networking opportunities.
• Employee resource groups, service programs, recognition programs, and volunteer opportunities.