Legend Biotech · 1 day ago
QA Change Control Specialist II
Raritan, NJ
Full-time
Onsite
Entry, Mid Level
$76K/yr - $100K/yr
2+ years expLegend Biotech is a global biotechnology company dedicated to treating life-threatening diseases through advanced cell therapies. The QA Change Control Specialist II will provide quality oversight over the change control process within a cell therapy manufacturing facility, ensuring compliance with clinical and commercial requirements in a sterile GMP environment.
BiotechnologyHealth CareLife ScienceOncologyTherapeutics
Hiring Manager
Breanna (Vazquez) Zalewski
Responsibilities
Support and streamline the site change control process
Participate in change control process from initiation through completion
Schedule and participate in the site change control review board meetings
Manage change control metrics reporting
Collaborate with functional departments to resolve issues
Support drafting of standard operating procedures
Support cross-functional projects with many stakeholders
Participate in the training program for new members
Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements
Review change controls, SOPs, and other documentation
Require minimal direction to complete tasks, knows how to get resources and information from established internal contacts; consult with supervisor for decisions outside established processes
Drive continuous improvement
Have advanced computer skills to increase department's productivity, as well as broadening technical and scientific knowledge
Works in a collaborative team setting with quality counterparts that include Manufacturing Operations, Quality Control, and Operations Technical Support
Qualification
Required
A minimum of a Bachelor's Degree in Science, Information Science or equivalent technical discipline is required
Minimum of 2 years relevant work experience is required
GxP Quality System knowledge, including relevant regulations and guidance (e.g. 21 CFR, ICH Q10, EU GDP/GMP, Part 11/Annex 11, PIC/S, MHRA)
Operational experience with electronic quality systems
Familiarity with core Quality Management System processes
Strong written and verbal communication skills, and analytical problem solving and conflict resolution skills
Flexible, highly motivated, with strong organization skills, ability to multitask with attention to detail
Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment
Effective interpersonal skills with the ability to communicate across all levels of the organization
Ability to work independently with a high degree of accountability
Proficient knowledge of Microsoft Office
Preferred
It is preferable that the candidate has experience working in a cGMP manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy
IT system lifecycle knowledge including requirements gathering, change management, implementation and continuous support is a plus
Experience in quality metrics reporting, analysis and process improvement techniques is a plus
Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint)
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
2025-12-18
Company data provided by crunchbase