Legend Biotech · 1 hour ago
Associate Manager, QA Shop Floor
Raritan, NJ
Full-time
Onsite
Entry, Mid Level
$76K/yr - $100K/yr
1+ years expLegend Biotech is a global biotechnology company dedicated to treating life-threatening diseases. The Associate Manager, QA Shop Floor is responsible for providing quality oversight over the production of personalized cell therapy in a sterile GMP environment and supervising QA shop floor personnel while troubleshooting issues with manufacturing.
BiotechnologyHealth CareLife ScienceOncologyTherapeutics
Responsibilities
Read, interpret, and revise documents such as SOPs, work instructions
Develop positive relationships with the QA team, Quality Control, Information Technology, Maintenance, Manufacturing personnel, Technical Operations personnel, Human Resources, Site Leadership Team members, and peers
Harmonize with Environmental, Health, and Safety personnel, Product Development, and Quality/Manufacturing personnel
Independently makes appropriate and compliant GMP decisions
Independently resolves problems using quality systems
Lead quality driven continuous improvement projects
Strive to reduce non-conformances in supported areas by dedicatedly driving compliance
Support QASF team growth and development
Must be able to be Aseptic Gown Qualified
Possess the ability to positively influence peers, key stakeholders, and management
Generates shift schedules, to ensure efficient coverage for all operational needs
Maintain quality practices in accordance with state and federal regulatory requirements
Supports the completion of corrective and preventive actions, as necessary
Supports internal/external audits
Supports Quality risk assessment teams
Review/approve documents as a Quality on the Floor Subject Matter Expert (SME)
Remain current in skills and industry trends
Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals
Distance visual acuity of at least 20/30 (Snellen) in both eyes without corrective lenses or visual acuity corrected to 20/30 (Snellen) or better with corrective lenses
Color Perception both eyes 5 slides out of 8
Qualification
Required
Bachelor's Degree in Science, Engineering or equivalent technical discipline is required
Minimum of 1 year relevant work experience, preferably within a biological and/or pharmaceutical industry is required
Knowledge of Good Tissue Practices is required
Excellent written and oral communication skill are required
Candidates must be able to accommodate shift schedule. Shifts include routine weekend and evening work as required by the manufacturing process
Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice
The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision
Comfortable with speaking and interacting with regulatory inspectors
This position may require occasional travel to partner sites in NJ or PA as business demands
This position may require up to 5% domestic or international travel as business demands
Takes responsibility for one's results and deliverables; sets and achieves goals to support organizational priorities
Takes initiative; willing to take unpopular positions/actions when necessary; courageous and assertive
Works effectively in the face of ambiguity, shifting priorities, and rapid change; maintains a positive outlook in difficult situations; a change agent
Identifies and focuses on activities of highest value and impact; makes informed decisions quickly
Results oriented; defines goals, metrics and actionable plans and manages work to deliver desired outcomes; has a sense of urgency
Considers resources, alternatives, constraints and desired outcomes to make effective decisions
Employs good project management principles to appropriately align time, resources, and budgets
Appreciates diverse perspectives and is actively inclusive of others' input and ideas; treats others with respect
Articulates ideas clearly and succinctly in a variety of settings and styles; can get messages across that have the desired effect
Leverages personal credibility and interpersonal skills to help others make better decisions and positively impact outcomes; able to develop/maintain effective working relationships internally and externally
Employs a global mindset in decision-making and errs on the side of over-communicating to create organizational transparency, trust and alignment
Takes initiative, actively shares knowledge, builds skills, promotes new ideas and embraces change
Generates new solutions to problems by challenging the status quo and conventional thinking
Preferred
Experience in a Quality Control setting is preferred
Experience with processing samples in biosafety cabinets utilizing aseptic technique is strongly preferred
Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products is strongly preferred
Knowledge of CAR-T QC test methods and related equipment is preferred
Benefits
Medical, dental, and vision insurance
401(k) retirement plan with a company match that vests fully on day one
Eight (8) weeks of paid parental leave after just three (3) months of employment
Paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company 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