QC Specialist (Biotech)

TL;DR

QC Specialist (Biotech): Managing laboratory samples and documentation for advanced cell therapy development with an accent on cGMP compliance and LIMS operations. Focus on coordinating sample shipments, performing inventory inspections, and conducting non-conformance investigations within a regulated pharmaceutical environment.

Location: Must be based in Raritan, NJ (Onsite)

Salary: $83,711–$109,870 USD

Company

A global biotechnology company developing innovative cell therapies to treat life-threatening diseases.

What you will do

• Manage QC sample intake, storage, and retain processes.
• Prepare and review technical documentation independently.
• Coordinate internal and external sample shipments.
• Perform periodic inspections and consolidation of retain samples.
• Document and handle non-conformance investigations and CAPA records.
• Support internal and regulatory audits.

Requirements

• Bachelor’s degree or higher in Biology, Biochemistry, Microbiology, or Chemistry.
• Minimum of two years of experience in the biopharmaceutical or pharmaceutical industry.
• Solid understanding of cGMP and regulatory requirements.
• Proficiency with Microsoft Office and LIMS software.
• Must be able to accommodate evening and weekend shift schedules.
• Must be located in Raritan, NJ.

Culture & Benefits

• Comprehensive medical, dental, and vision insurance.
• 401(k) retirement plan with immediate company match.
• Eight weeks of paid parental leave after three months.
• Generous paid time off including vacation, sick time, and eleven company holidays.
• Access to well-being initiatives and family planning resources.