QC Technical Trainer III jobs in United States
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Legend Biotech · 2 days ago

QC Technical Trainer III

Legend Biotech is a global biotechnology company dedicated to treating and curing life-threatening diseases. They are seeking a QC Technical Trainer III to perform training activities for the Quality Control Microbiology team and ensure compliance with cGMP regulations in cell therapy testing.

BiotechnologyHealth CareLife ScienceOncologyTherapeutics
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H1B Sponsor Likelynote
Hiring Manager
Breanna (Vazquez) Zalewski
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Responsibilities

Lead, coach, and deliver trainings for the Quality Control Microbiology team and Operations team (as needed)
Be responsible for conducting training and qualifying QC Microbiology Specialists on QC test methods
Work closely with QC Onboarding Associate(s)/QC Leads/Supervisors to ensure planned training events were completed as scheduled and provide feedback as needed
Conducts Observation, Side-by-Side, and Instructor Led Training inside of laboratory and CAR-T cGMP Manufacturing facility
Conducts knowledge and skill check and independent performance qualifications for Quality Control Microbiology inside of laboratory and CAR-T cGMP Manufacturing facility
Ensure testing and training is completed in compliance with all applicable procedures, standards and GMP regulations
Support day to day Quality Control Microbiology activities as needed
Perform peer review/ approval of laboratory data as needed
Helps write or revise SOPs, Work Instructions, Job Aids, knowledge, and skills assessments
Optimizes the effectiveness and efficiency of training program in delivery of qualified personnel
Work cross functionally with the training team to ensure the development/ qualification processes
Supports investigations and evaluates improvement opportunities for effective compliant training performance leading to sustained right first-time execution
Provide awareness trainings to the Quality Control Microbiology team
Performs trainings within CAR-T manufacturing facility inside of cleanroom environments
Serve as subject matter expert for Learning Management Systems
Support the maintenance and reporting of quality training metrics
Other duties will be assigned, as necessary

Qualification

Quality Control MicrobiologyCGMP regulationsTraining methodologyAseptic manufacturingCAR-T QC test methodsLearning Management SystemsCommunicationOrganizational skillsTeam collaboration

Required

A minimum of a Bachelor's Degree in Science, Engineering or equivalent technical discipline is required
A Minimum of 0-2 years relevant work experience, preferably within a biological and/or pharmaceutical industry is required
Experience with biosafety cabinets is required
Candidate must have experience working within an aseptic manufacturing facility, preferably within quality control, quality assurance, training/systems applications, quality systems, or learning management systems
Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products is required
Knowledge of Good Tissue Practices is required
Detailed knowledge of CAR-T QC test methods and related equipment is required
Excellent written and oral communication skill are required
Candidates must be able to accommodate occasional 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 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

Preferred

Experience in a Quality Control setting
Experience with training methodology, adult learning theory, and train-the-trainer programs
Curriculum and module design experience

Benefits

Medical, dental, and vision insurance
401(k)-retirement plan with company match that vest fully on day one
Equity and stock options
Eight weeks of paid parental leave after just three months of employment
Paid time off policy that includes vacation days, personal days, sick time, 11 company 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

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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