QA Shop Floor Specialist (Biotech)

TL;DR

QA Shop Floor Specialist (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 ensuring sterility, managing non-conformances, and supporting regulatory audits to maintain the highest standards of product quality.

Location: Must be based in Raritan, NJ (On-site role)

Salary: $78,251 – $102,705 USD

Company

A global biotechnology company developing advanced cell therapies for life-threatening diseases.

What you will do

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

Requirements

• Bachelor’s degree in Life Sciences or Engineering required.
• Must be able to work on-site in Raritan, NJ.
• 0-2+ years of experience in biotech or pharmaceutical manufacturing.
• Relevant experience in an aseptic manufacturing facility, preferably in quality assurance or compliance.
• Proficiency with SAP, electronic batch records, and quality systems.
• Ability to aseptically gown for Grade B cleanroom environments.

Culture & Benefits

• Comprehensive 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.
• Generous paid time off policy including vacation, sick, and personal time.
• Supportive culture with well-being initiatives and family planning resources.