Legend Biotech · 1 month ago
Specialist, QA Process Excellence
Raritan, New Jersey, United States
Full-time
Onsite
Mid, Senior Level
$76K/yr - $100K/yr
5+ years expLegend Biotech is a global biotechnology company dedicated to treating life-threatening diseases. The Specialist, QA Process Excellence will provide quality oversight for the manufacturing process and associated technical activities within a cell therapy manufacturing plant to support clinical and commercial requirements in a sterile GMP environment.
BiotechnologyHealth CareLife ScienceOncologyTherapeutics
Responsibilities
Provide Quality Oversight and technical expertise to the Technical Operations and Manufacturing Teams in support of technical activities
Provides guidance on industry best practices, and quality requirements for maintaining a compliant state for manufacturing operations
Provide expertise related to investigations and deviations occurring during routine manufacturing and protocol-driven activities such as tech transfer and process validation
Assist in the development of process, operational, and quality improvements for manufacturing
Assist in the review and development of process-related protocols and documentation
Provide technical quality oversight for electronic batch records
Support manufacturing and technical operations teams in trouble shooting and resolving complex scientific / technical problems
Evaluates quality processes and system standards to ensure compliance with applicable internal standards, industry standards, and global regulations
Provide Quality Oversight for batch records, change controls, SOPs, non-conformances, risk assessments, and CAPAs associated with manufacturing and technical operations and ensure effectiveness of related actions
Ability to handle multiple priorities daily while being flexible and responsive to frequently shifting priorities
Ability to work independently perform assigned tasks
Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements
May support CSV activities as needed
May support equipment qualification activities as needed
Drive continuous improvement
Qualification
Required
A minimum of a Bachelor's Degree in Science or equivalent technical discipline is required
5+ years relevant work experience or equivalent
It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy
A portion of the 5 years must include quality assurance experience
Knowledge of cGMP regulations and FDA/EU guidance related to GMP manufacturing of biopharmaceuticals
Experience reviewing/auditing GMP documentation
Strong interpersonal and written/oral communication skills
Ability to quickly process complex information and make critical decisions with limited information
Ability to work independently and escalate to management when required
Detail-oriented and able to follow procedures closely
Ability to identify and assess possible gaps and work collaboratively to address such issues
Must be highly organized and capable of working in a team environment with a positive attitude
Strong proficiency with using Microsoft Office applications
Preferred
Strong knowledge of cell therapy processes strongly preferred
Experience with Manufacturing Execution Systems (MES) design/development and validation is preferred
Experience with Computer System Validation (CSV) is a plus
Benefits
Medical, dental, and vision insurance
401(k)-retirement plan with company match that vest fully on day one
Equity and stock options are available to employees in eligible roles
Eight weeks of paid parental leave after just three months of employment
Paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays
Flexible spending and health savings accounts
Life and AD&D insurance
Short- and long-term disability coverage
Legal assistance
Supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance
Commuter benefits
Family planning and care resources
Well-being initiatives
Peer-to-peer recognition programs
Company
Legend Biotech
Legend Biotech is a biopharmaceutical company that develops and commercializes novel cell therapies for oncology.
1001-5000 employees
H1B Sponsorship
Legend Biotech has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (30)
2024 (11)
2023 (14)
2022 (7)
2021 (6)
2020 (13)
Funding
Current Stage
Public CompanyTotal Funding
$750.45M2023-05-05Post Ipo Equity· $350M
2022-07-25Post Ipo Equity· $250M
2020-06-05IPO
Leadership Team
Carlos Santos
Chief Financial Officer
Alan Bash
President, CARVYKTI
Recent News
legacy.thefly.com
2026-01-22
2026-01-22
Company data provided by crunchbase