Job details

QA Validation Specialist III

Legend Biotech is a global biotechnology leader advancing innovative cell therapies for life-threatening diseases. We are seeking a QA Validation Specialist III to provide quality oversight for validation and qualification activities within our cell therapy manufacturing facility in Raritan, NJ.

Skills

Strong knowledge of cGMP, GxP compliance, FDA/EU GMP regulations
Experience with auditing GMP documentation and regulatory audits
Proficient in Microsoft Office applications
Ability to analyze complex information and make effective decisions
Strong interpersonal and communication skills
Excellent organizational skills and attention to detail
Ability to work independently and manage multiple projects

Responsibilities

Provide quality and compliance oversight for validation and qualification of equipment, systems, computer systems, utilities, facilities, shipping, and data integrity
Review and approve qualification/validation documentation including protocols and reports
Provide expertise and solutions for validation strategies and maintain compliance with industry standards
Assist in developing validation-related policies, procedures, templates, and forms
Oversee data integrity and quality processes ensuring compliance with Legend and global regulations
Collaborate across Quality and Technical Services on system deployments at the CAR-T Raritan site
Review and approve change controls, SOPs, non-conformances, and CAPAs linked to validation activities
Comply with safety policies, quality systems, and cGMP requirements
Drive continuous improvement initiatives

Education

Bachelor’s Degree in Science or equivalent technical discipline

Benefits

Medical, dental, and vision insurance
401(k) retirement plan with company match fully vested from day one
Equity and stock options for eligible employees
Eight weeks paid parental leave after three months of employment
Paid time off including vacation, personal, sick days, national and floating holidays
Flexible spending and health savings accounts
Life and AD&D insurance, short- and long-term disability coverage
Legal assistance and supplemental insurance plans
Commuter benefits, family planning and care resources
Well-being initiatives and peer-to-peer recognition programs

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QA Validation cGMP GxP cell therapy biopharmaceutical process validation computer systems validation quality assurance manufacturing compliance FDA audits documentation review risk assessment SOP CAPA Raritan biotech

Average salary estimate

$108066.5 / YEARLY (est.)

min

max

$93463K

$122670K

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Legend Biotech US

Legend Biotech is a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications.

12 jobs

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FUNDING

Private

DEPARTMENTS

Quality Assurance

SENIORITY LEVEL REQUIREMENT

Mid-Level

INDUSTRY

Health Care

TEAM SIZE