QC Lab Services Specialist - cGMP & Sample Management

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

Benefits offered by this job

Medical insurance

401(k) with company match

Paid parental leave

Job summary

Legend Biotech, based in Bridgewater, New Jersey, is seeking a QC Specialist, Lab Services I for the US Quality team in Raritan, NJ. The role focuses on sample management and ensures compliance with cGMP in the QC laboratory.

Candidates should have a BS or higher, 2+ years in medical device/pharma, and experience with LIMS and quality systems. This full-time role may require up to 5% travel and offers a competitive base salary and benefits.

Qualifications

• BS or higher in Biology, Biochemistry, Microbiology, Chemistry or related field.
• 2+ years in medical device, biopharmaceutical, or pharmaceutical industry.
• Solid understanding of regulatory requirements, policies and guidelines.
• Experience with Quality Control document reviews and regulatory inspection processes.

Responsibilities

• Prepare and review QC documentation.
• Manage QC samples and retains.
• Knowledge of cGMP related to QC lab and identify gaps.
• Proficient with MS Office and LIMS.
• Coordinate sample shipments (internal and external).
• Review logbooks and align sample quantities in freezers.

Skills

Quality control

LIMS

cGMP

Documentation

MS Office

Education

Bachelor’s degree or higher

Tools

eLIMS

Job description

Legend Biotech, based in Bridgewater, New Jersey, is seeking a QC Specialist, Lab Services I for the US Quality team in Raritan, NJ. The role focuses on sample management and ensures compliance with cGMP in the QC laboratory.

Candidates should have a BS or higher, 2+ years in medical device/pharma, and experience with LIMS and quality systems. This full-time role may require up to 5% travel and offers a competitive base salary and benefits.