Legend Biotech · 2 days ago
QA Shop Floor Specialist II
Raritan, New Jersey, United States
Full-time
Onsite
New Grad, Entry Level
$76K/yr - $100K/yr
0+ years expLegend Biotech is a global biotechnology company focused on developing advanced cell therapies. They are seeking a QA Shop Floor Specialist II to oversee quality during the production of CAR-T products in a cGMP cleanroom environment, ensuring compliance with company policies and regulations.
BiotechnologyHealth CareLife ScienceOncologyTherapeutics
Responsibilities
Provide Quality oversight of all aspects of the cell therapy clinical manufacturing process
Support manufacturing activities for cGMP compliance through spot checks/internal audits
Collaborate with site personnel to provide guidance and determine immediate path forward for manufacturing quality issues
Review of all documentation, in accordance with Good Documentation Practices (GDP)
Review, revise, or draft Standard Operating Procedures (SOPs)
Support processes that include aseptic process simulations, Commercial & clinical manufacturing, miscellaneous runs that are conducted to support manufacturing to ensure sterility of the product/process is not compromised
Support batch review & material release in SAP for In-house reagents
Support Floor Spot-check, audit trail review
Strive to reduce non-conformances in supported areas by proactively driving compliance
Support Investigations team by providing quality and compliance input for continuous improvement and remediations
Serve as a backup for approving printed labels and documents prior to use on the manufacturing floor
Utilize multiple electronic quality systems, batch records and SAP
Work in a team based, cross-functional environment to complete tasks required to meet business objectives
Must be able to aseptically gown to Support Grade B Clean rooms / practice aseptic behavior in controlled areas
Provide QA shop floor support for extended periods of time
Responsibilities will include but not limited to tasks mentioned above
Support regulatory inspections and audits as needed
Consistently perform tasks in adherence with safety policies, quality systems, and cGMP requirements, as well as according to state and federal regulatory requirements
Other duties will be assigned
Qualification
Required
Bachelors degree required in Life Sciences or Engineering
0-2+ years Biotech/Pharmaceutical experience or equivalent industry experience
Must have relevant working experience in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, technical operations or cell therapy
Flexible to work on weekends, as needed
Needs to be mobile and able to independently transport themselves between various sites/locations, as dictated by the essential functions and responsibilities of the position
Is frequently required to communicate with coworkers
While performing the duties of this job, the employee is regularly required to stand; walk; climb, bend and stoop; and reach with hands and arms
Ability to lift 20 lbs
Report to work on-time
Duties are required to be performed on-site at manufacturing facility
Perform other duties as assigned
Attend departmental and other scheduled meetings
Practice good interpersonal and communication skills
Demonstrate positive team-oriented approach in the daily execution of procedures
Promote and work within a team environment
Learn new skills, procedures and processes as assigned by management and continue to develop professionally
Support and contributes to projects
Assist in troubleshooting issues related to manufacturing
Technical knowledge within functional units
Demonstrate an understanding of the process in order to properly perform the assigned tasks
Strong proficiency utilizing relevant manufacturing applications (SAP), electronic batch records (EBR), and quality systems
Utilizes tools within MS Office and other systems to improve business effectiveness
Read and interpret documents such as safety rules, operating instructions, and logbooks
Review and provide feedback for SOPs
Interpret a variety of instructions furnished in written, oral, or diagram
Ability to deal with complexity across the drug product, the associated manufacturing process, and the end-to-end supply chain process
Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists
Add, subtract, multiply and divide in all units of measure, using whole numbers, common factions, and decimals
Aseptic processing in ISO 5 clean room and biosafety cabinets
Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices
Great attention to detail and ability to follow the procedures
The candidate must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision
Good written and verbal communication skills are required
Ability to summarize and present results, and experience with team-based collaborations is a must
Must be able to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk
Ability to collaborate well with stakeholders, customers and peers
Must exhibit strong decision-making ability and think creatively while maintaining compliance and quality
Must be able to discern the criticality of issues and to communicate to management regarding complex issues
Ability to manage conflict and issues that arise with internal or external customers
Preferred
Experience with quality support in clinical manufacture is preferred
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 vacation days, personal days, sick time, 11 company 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
2025-12-18
thefly.com
2025-12-09
Company data provided by crunchbase