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Full-Time

QA Shop Floor Supervisor

Posted on 6/18/2024

Legend Biotech

Legend Biotech

1,001-5,000 employees

Develops cell therapies for cancer treatment

Hardware
Biotechnology

Senior

Bridgewater Township, NJ, USA

Category
QA & Testing
Quality Assurance
Required Skills
Quality Assurance (QA)
Requirements
  • Minimum of a Bachelor’s Degree in Science, Information Science or equivalent technical discipline
  • Minimum of 6 years relevant work experience
  • Experience working in an aseptic manufacturing facility
  • Minimum of 2 years of experience with quality support in clinical manufacture
  • Minimum of 1 year of leadership experience
  • Knowledge of cGMP regulations and FDA/EU guidance
  • Strong interpersonal and written/oral communication skills
  • Ability to handle multiple priorities and make critical decisions
  • Proficient in process excellence tools and methodologies
  • Excellent organizational skills
  • Experience with team-based collaborations
  • Experience directly supervising employees
  • Detailed knowledge of cGMP and cGTP related to CAR-T manufacturing
  • Experience with ICH and/or 21 CFR parts
  • Proficient in Microsoft Office applications
  • Flexibility to work on weekends
Responsibilities
  • Read, interpret and revise documents such as SOPs and work instructions
  • Develop positive relationships with various departments
  • Independently make compliant GMP decisions
  • Resolve problems through quality systems
  • Develop improvement ideas and implement solutions
  • Generate shift schedules for operational needs
  • Maintain individual training completion
  • Support corrective and preventive actions
  • Support internal/external audits
  • Support Quality risk assessment teams
  • Review/approve documents as a Quality on the Floor Subject Matter Expert
  • Remain current in skills and industry trends

Legend Biotech specializes in developing and manufacturing novel cell therapies for hematologic malignancies and solid tumors, leveraging cutting-edge technologies to deliver advanced treatment options for patients worldwide. The company's pipeline of cell therapies includes agents targeting diseases considered intractable and incurable, with a focus on transforming the world of oncology and medicine.

Company Stage

IPO

Total Funding

$750.5M

Headquarters

Franklin Township, New Jersey

Founded

2014

Growth & Insights
Headcount

6 month growth

19%

1 year growth

36%

2 year growth

92%
INACTIVE