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Full-Time

QA Document Control Specialist

2nd Shift

Confirmed live in the last 24 hours

Legend Biotech

Legend Biotech

1,001-5,000 employees

Develops and commercializes cell therapies

Biotechnology
Healthcare

Junior, Mid

Bridgewater Township, NJ, USA

Position requires onsite presence in Raritan, New Jersey.

Category
QA & Testing
Quality Assurance
Required Skills
Quality Assurance (QA)
PowerPoint/Keynote/Slides
Requirements
  • A minimum of a Bachelor’s Degree in Science, Information Science or equivalent technical discipline is required.
  • A minimum of 2 years relevant work experience is required. It is preferable that the candidate has experience working in a cGMP manufacturing facility, quality assurance, manufacturing compliance, clinical quality, or cell therapy.
  • Must be able to work 2nd shift, Wednesday - Saturday 2PM-12AM
  • GxP Quality System knowledge, including relevant regulations and guidances (e.g. 21 CFR, ICH Q10, EU GDP/GMP, Part 11/Annex 11, PIC/S, MHRA).
  • Operational experience with electronic quality systems.
  • Strong written and verbal communication skills, and analytical problem solving and conflict resolution skills.
  • Flexible, highly motivated, with strong organization skills, ability to multi task with attention to detail.
  • Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
  • Flexibility in work schedule is required.
  • 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 with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint).
Responsibilities
  • Issuance of batch related documentation and labels in support of GMP manufacturing.
  • Reconcile GMP documentation following document lifecycle requirements.
  • Creation and issuance of GMP logbooks/notebooks.
  • Responsible for storage and archival of GMP documents and batch related records.
  • Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
  • Drive continuous improvement.
  • Help increase department's productivity, as well as broadening technical and scientific knowledge.

Legend Biotech develops and sells cell therapies aimed at treating serious diseases, particularly cancers like hematological malignancies and solid tumors. Their approach is technology agnostic, allowing them to explore various methods to find effective treatments. The company operates in the personalized medicine sector, focusing on discovering, developing, and bringing new therapies to market. They generate revenue through licensing and selling their therapies, including CAR-T therapies, which involve modifying a patient's own cells to combat cancer. Unlike many competitors, Legend Biotech emphasizes transparency with investors, regularly updating them on financial results and business developments. Their goal is to provide effective treatments for hard-to-treat diseases through innovative cell therapy solutions.

Company Stage

IPO

Total Funding

$750.5M

Headquarters

Franklin Township, New Jersey

Founded

2014

Growth & Insights
Headcount

6 month growth

17%

1 year growth

41%

2 year growth

96%
Simplify Jobs

Simplify's Take

What believers are saying

  • Legend Biotech's recent European Commission approval for CARVYKTI® positions it as a leader in the multiple myeloma treatment market.
  • Strategic partnerships, such as the one with MaxCyte, enhance Legend Biotech's capabilities in cell engineering and expand its technological reach.
  • The company's commitment to transparency and investor relations, demonstrated through regular financial updates, fosters investor confidence and long-term stability.

What critics are saying

  • The competitive landscape in cell therapy and personalized medicine is intense, requiring continuous innovation to maintain market position.
  • Regulatory hurdles and the need for extensive clinical trials can delay the commercialization of new therapies, impacting revenue streams.

What makes Legend Biotech unique

  • Legend Biotech's technology-agnostic approach allows it to explore multiple innovative therapies, unlike competitors who may focus on a single technology.
  • The company's comprehensive business model, from discovery to commercialization, ensures control over the entire treatment lifecycle, providing a competitive edge.
  • Legend Biotech's strong focus on CAR-T therapies, particularly for hematological malignancies and solid tumors, sets it apart in the personalized medicine sector.