QA Shop Floor Specialist II (Biotech)

TL;DR

QA Shop Floor Specialist II (Biotech): Providing quality oversight for the production of autologous CAR-T cell therapies in a cGMP cleanroom environment with an accent on compliance, aseptic process monitoring, and documentation review. Focus on supporting manufacturing operations, conducting spot checks, and ensuring adherence to regulatory standards for clinical and commercial products.

Location: Must be based in Raritan, New Jersey (On-site)

Salary: $96,267 - $126,351 USD

Company

hirify.global is a global biotechnology company developing advanced cell therapies, including CAR-T and NK cell-based immunotherapies, to treat life-threatening diseases.

What you will do

• Provide quality oversight for cell therapy clinical manufacturing processes.
• Conduct spot checks and internal audits to ensure cGMP compliance.
• Review and draft Standard Operating Procedures (SOPs) and batch documentation.
• Collaborate with cross-functional teams to resolve manufacturing quality issues.
• Support aseptic process simulations and material release in SAP.
• Provide quality input for investigations and continuous improvement initiatives.

Requirements

• Bachelor’s degree in Life Sciences or Engineering required.
• Must be able to work on-site in Raritan, New Jersey.
• 0-2+ years of experience in biotech or pharmaceutical industry.
• Experience in aseptic manufacturing, quality assurance, or technical operations.
• Proficiency with SAP, electronic batch records, and quality systems.
• Knowledge of cGMP regulations and FDA/EU guidance for cell-based products.

Culture & Benefits

• Medical, dental, and vision insurance.
• 401(k) retirement plan with company match vesting on day one.
• Eight weeks of paid parental leave after three months of employment.
• Comprehensive paid time off policy including vacation, sick, and personal time.
• Additional benefits include life insurance, disability coverage, and family planning resources.