QC Lab Services Specialist: Sample & Retain Management

Legendcareers; Raritan (NJ); On-site; USD 63,000 - 83,000; Full time

Job summary

Legend Biotech in Raritan, NJ is seeking a QC Specialist, Lab Services I to join the US Quality team. The role focuses on sample management, cGMP compliance, and collaboration with QA/regulatory functions.

A Bachelor's degree and 2+ years in the field are required, with experience in LIMS/eLIMS; weekend/evening shifts and up to 5% travel. Eligible candidates will work in a fast-paced environment, supporting audits and documentation accuracy while maintaining alignment with regulatory

Qualifications

• Bachelor’s degree or higher in biology, biochemistry, microbiology, chemistry, or a related field.
• Minimum of two years' related experience in medical device, biopharmaceutical, or pharmaceutical industry.
• Solid understanding of regulatory requirements and quality systems.
• Experience with QC document reviews and regulatory inspection processes.
• Experience managing retain samples using electronic systems (eLIMS).
• Willing to accommodate shift schedules, including weekends and evenings.
• Located in Raritan, NJ with up to 5% travel.
• Ability to lift up to 20 pounds occasionally.

Responsibilities

• Prepare and review documentation independently.
• Manage QC samples and retains.
• Ensure cGMP compliance in QC laboratory operations.
• Utilize MS Office and LIMS for data management.
• Coordinate sample shipments (internal and external).
• Review logbooks and LIMS to align sample quantities.
• Perform retains inspection and consolidation.
• Document non-conformance investigations and CAPA.
• Support internal and regulatory audits.

Skills

Quality Control

Documentation Review

Regulatory Knowledge

Problem Solving

Shift Availability

Education

Bachelor's degree or higher in Biology/Biochemistry/Microbiology/Chemistry

Tools

LIMS

eLIMS

Microsoft Office

Job description

Legend Biotech in Raritan, NJ is seeking a QC Specialist, Lab Services I to join the US Quality team. The role focuses on sample management, cGMP compliance, and collaboration with QA/regulatory functions.

A Bachelor's degree and 2+ years in the field are required, with experience in LIMS/eLIMS; weekend/evening shifts and up to 5% travel. Eligible candidates will work in a fast-paced environment, supporting audits and documentation accuracy while maintaining alignment with regulatory