QA Document Control Specialist jobs in United States
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Legend Biotech · 1 week ago

QA Document Control Specialist

Legend Biotech is a global biotechnology company focused on developing innovative cell therapies. The Quality Assurance Document Control Specialist plays a critical role in managing document integrity and compliance in a GMP-controlled environment, ensuring that all documentation meets regulatory standards and supports the manufacturing process.

BiotechnologyHealth CareLife ScienceOncologyTherapeutics
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H1B Sponsor Likelynote

Responsibilities

Document Management: You manage our document control systems, ensuring every process aligns seamlessly with our operational needs. Your oversight guarantees the smooth management of vital documentation throughout the site
Review and Compliance: You review new and revised procedures and documents to ensure they meet stringent global and site-specific standards. Your keen eye for detail ensures every document reflects our commitment to quality and compliance
System Support and Management: You will increase user engagement with our Document Management System by providing the necessary support and guidance. You manage workflow processes efficiently so that each team member can apply them quickly and easily
Documentation Issuance: You oversee the issuance of batch-related documentation, a cornerstone of our GMP manufacturing process. Your role is to ensure that every batch produced meets our high standards and regulatory requirements
Document Lifecycle Management: You handle the reconciliation and archiving of GMP documentation, maintaining a meticulous record of our manufacturing journey. Your attention to detail ensures the integrity and accessibility of vital records for both current operations and future audits

Qualification

Document ManagementGMP ComplianceMicrosoft OfficeWritten CommunicationMultitaskingTeam PlayerProblem-SolvingAttention to Detail

Required

You have a secondary school or bachelor's degree
We offer extensive, in-house training after which you can start working smoothly in your new role
You are proficient in Dutch and/or English, with strong written and oral communication skills
You have a strong sense of responsibility, are highly motivated and well-organized, and are capable of multitasking
You are a real team player but can also work well independently
You have a positive and problem-solving mindset and an eye for detail
You can work smoothly with Microsoft Office applications, such as Outlook, Excel, Word, and PowerPoint

Benefits

Additional legal vacation days
Meal vouchers
Group and hospitalization insurance
End of year bonus
Performance bonus

Company

Legend Biotech

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Legend Biotech is a biopharmaceutical company that develops and commercializes novel cell therapies for oncology.

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 Company
Total Funding
$750.45M
2023-05-05Post Ipo Equity· $350M
2022-07-25Post Ipo Equity· $250M
2020-06-05IPO

Leadership Team

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Carlos Santos
Chief Financial Officer
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Alan Bash
President, CARVYKTI
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Company data provided by crunchbase