QA, Shop Floor Specialist II (Biotech)

Location: On-site in Raritan, New Jersey, United States. The role requires work at the manufacturing facility, aseptic gowning in Grade B cleanrooms, extended floor support, and weekend flexibility as needed. Applicants must be authorized to work in the United States; employment eligibility is verified through E-Verify.

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

Company

hirify.global is a biotechnology company developing cell therapies, including autologous, allogeneic, and in vivo platforms and CAR-T products such as CARVYKTI®.

What you will do

• Provide quality oversight for clinical and commercial autologous CAR-T manufacturing in a controlled cGMP cleanroom environment.
• Support manufacturing compliance through floor spot checks, internal audits, audit-trail reviews, and regulatory inspections.
• Review manufacturing documentation, electronic batch records, labels, and SOPs in accordance with Good Documentation Practices.
• Support aseptic process simulations, manufacturing runs, batch review, and material release in SAP.
• Provide quality input to investigations, remediation, troubleshooting, and continuous improvement initiatives.
• Collaborate with Manufacturing Operations, Technical Operations, Maintenance, Supply Chain, Planning, and other quality counterparts.

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; experience in quality assurance, manufacturing compliance, clinical quality, technical operations, or cell therapy is preferred.
• Knowledge of cGMP regulations, FDA/EU guidance for cell-based products, and Good Tissue Practices.
• Experience with aseptic processing in ISO 5 cleanrooms and biosafety cabinets.
• Strong proficiency with SAP, electronic batch records, quality systems, and Microsoft Office; ability to work on-site, stand, walk, climb, bend, stoop, and lift 20 lbs.

Culture & Benefits

• Collaborative, cross-functional team environment with opportunities to support projects and develop new skills.
• Medical, dental, and vision insurance, plus a 401(k) plan with company match fully vested 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 benefits include disability coverage, life insurance, flexible spending and health savings accounts, commuter benefits, family-care resources, and well-being programs.
• Benefits are available exclusively to permanent full-time employees; contractors are not eligible for hirify.global benefits.