QC Specialist Role at Legend Biotech USA
Legend Biotech is hiring a QC Specialist for Lab Services II/III in Raritan, NJ. This quality control job involves managing QC samples, documentation, and supporting regulatory compliance to ensure the highest standards in biopharmaceutical operations. Join Legend Biotech and contribute to life-saving therapies worldwide.
Job Details:
- Job Title: QC Specialist, Lab Services II/III
- Location: Raritan, NJ
- Employment Type: Full-time
- Industry: Biotechnology / Biopharmaceuticals
- Experience Required: Minimum 2 years in QC or related field
- Shift Requirements: May include evenings and weekends
- Travel: Up to 5% occasional travel
- Salary Range: $70,671 – $92,757 USD
About the Company:
Legend Biotech is a global biotechnology company focused on developing innovative cell therapies, including CAR-T, TCR-T, and NK cell-based immunotherapies. Headquartered in Somerset, NJ, Legend Biotech collaborates globally, including a partnership with Janssen (Johnson & Johnson) to develop therapies like ciltacabtagene autolecuel (cilta-cel) for multiple myeloma. The company is committed to improving patient outcomes worldwide. Explore more Quality control job offers.
Educational Requirements:
- Bachelor’s degree or higher in Biology, Biochemistry, Microbiology, or related field
- Strong understanding of regulatory requirements and quality systems
Key Responsibilities for QC Specialist Role:
- Independently prepare and review QC documentation
- Manage QC samples and retain samples in compliance with cGMP
- Use Microsoft Office and LIMS for lab management
- Coordinate internal and external sample shipments
- Review logbooks and LIMS to reconcile sample storage
- Conduct periodic inspections and consolidation of retains
- Investigate non-conformance in sample management
- Document and handle corrective and preventative action records
- Support internal and regulatory audits
Skills Required for QC Specialist Role:
- Knowledge of Quality Control processes and cGMP regulations
- Experience with QC documentation and regulatory inspections
- Proficiency with lab management software (eLIMS) and Microsoft Office
- Strong organizational and problem-solving skills
- Ability to work independently and as part of a team
- Flexible to work shifts including weekends and evenings
Benefits of the QC Specialist Role:
- Comprehensive medical, dental, and vision insurance
- 401(k) retirement plan with company match
- Equity and stock options (eligible roles)
- Paid parental leave, vacation, personal, and sick days
- Paid U.S. holidays and floating holidays
- Flexible spending accounts and health savings accounts
- Life and disability coverage, legal assistance, commuter benefits
- Family planning, well-being programs, and peer recognition initiatives
