QA Shop Floor Specialist II (Cell Therapy)

Location: On-site at the manufacturing facility in Raritan, New Jersey, United States

Base pay: $78,251–$102,705 USD per year. Performance-based bonus and/or equity may be available for eligible roles.

Company

hirify.global is a global biotechnology company developing cell therapies, including CAR-T, TCR-T, and NK cell-based therapies for serious diseases.

What you will do

• Provide quality oversight for clinical and commercial autologous CAR-T manufacturing in controlled cGMP cleanrooms.
• Support manufacturing compliance through floor checks, internal audits, audit-trail reviews, and regulatory inspections.
• Review batch records, manufacturing documentation, SOPs, labels, and in-house reagent releases in SAP.
• Support aseptic process simulations, manufacturing runs, investigations, troubleshooting, and continuous improvement.
• Guide site personnel in resolving manufacturing quality issues and reducing non-conformances.
• Work cross-functionally while following safety policies, quality systems, cGMP requirements, and applicable regulations.

Requirements

• Bachelor’s degree in Life Sciences or Engineering.
• 0–2+ years of biotechnology, pharmaceutical, or equivalent industry experience.
• Relevant experience in an aseptic manufacturing facility; quality assurance, manufacturing compliance, clinical quality, technical operations, or cell therapy experience is preferred.
• Knowledge of aseptic processing in ISO 5 cleanrooms and biosafety cabinets, cGMP regulations, FDA/EU guidance for cell-based products, and Good Tissue Practices.
• Strong proficiency with SAP, electronic batch records, quality systems, and Microsoft Office.
• Must be authorized to work in the United States; duties must be performed on-site at the manufacturing facility.

Culture & Benefits

• Permanent full-time employment with medical, dental, and vision insurance.
• 401(k) retirement plan with company match vesting fully on day one.
• Eight weeks of paid parental leave after three months of employment.
• Paid vacation, personal and sick time, floating holidays, and eleven company holidays.
• Additional voluntary benefits include flexible spending and health savings accounts, disability coverage, commuter benefits, family planning resources, and well-being programs.