QA Laboratory Compliance Specialist III (Biotech)

TL;DR

QA Laboratory Compliance Specialist III (Biotech): Providing quality and compliance oversight for Quality Control Laboratories testing advanced therapy products with an accent on GMP adherence and regulatory requirements. Focus on managing complex investigations, performing root cause analysis, and ensuring site audit-readiness for regulatory inspections.

Location: On-site in Raritan, New Jersey, United States (required to be on-site all days of the week)

Salary: $83,711 - $109,870 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 QA oversight for Quality Control laboratories to ensure adherence to global standards and regulatory requirements.
• Perform spot-checks, ad-hoc walk-throughs, and formbook reviews to drive compliance and reduce non-conformances.
• Lead complex investigations by collaborating with cross-functional teams to determine root causes and implement CAPAs.
• Train and coach Level I/II QALC staff on day-to-day compliance activities.
• Support regulatory inspections and audits by ensuring lab areas are in an audit-ready state.
• Monitor investigation lifecycles to ensure timely closure and update quality metrics.

Requirements

• Bachelor’s Degree in Science or an equivalent technical discipline.
• Minimum of 2 years of relevant work experience, with at least 1 year specifically in Quality Assurance.
• Strong knowledge of Nonconformance and CAPA management processes.
• Expertise in cGMP/cGLP regulations and FDA/EU guidance for biopharmaceutical manufacturing.
• Experience with cell-based products or CAR-T cell therapy is highly preferred.
• Must be able to work on-site in Raritan, NJ full-time.

Culture & Benefits

• Comprehensive medical, dental, and vision insurance.
• 401(k) retirement plan with a company match that vests immediately.
• Generous paid parental leave (8 weeks) after 3 months of employment.
• Paid time off including vacation, personal, sick time, and 11 company holidays.
• Flexible spending and health savings accounts (FSA/HSA).
• Additional perks including commuter benefits, legal assistance, and well-being initiatives.