Quality Assurance Specialist
OkloSalary not specified
Full Time
Junior (1 to 2 years)
Not SpecifiedCompensation
Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Biotechnology, PharmaceuticalsIndustries
Requirements
- A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline
- A minimum of 2-4 years relevant work experience (preferable in aseptic manufacturing facility, quality assurance, manufacturing compliance, clinical quality, or cell therapy)
- Knowledge of cGMP and GDP regulations and FDA/EU guidance related to manufacture of cell based products
- Great attention to detail and ability to follow procedures
- Highly organized and capable of working in a team environment with a positive attitude under minimal supervision
- Excellent organizational skills with the ability to simplify and clearly communicate complex concepts
- Excellent verbal, written and presentation capabilities
- Ability to summarize and present results
Responsibilities
- Ensure the timely completion of high-quality robust investigations with appropriate root cause(s)
- Ensure appropriate Corrective and Preventative Actions (CAPAs) are developed and implemented
- Escalate events to management that potentially represent significant quality issues or issues resulting in the delay of investigation closure and product release
- Support regulatory inspections and audits by ensuring inspection readiness within facility and serving as an SME during the execution of regulatory inspections and audits as needed
- Support compliance activities for site Quality Operations in accordance with Legend standards, procedures and cGMPs
- Collaborate with site personnel to provide guidance and determine resolution for end-to-end manufacturing issues
- Ensure accurate and timely maintenance and review of manufacturing investigations, CAPAs, change controls and complaints
- Perform analysis on quality indicating data and identifying trends
- Contribute to maintain investigation compliance metrics
- Support investigation process improvement initiatives
Skills
GMP
CAPA
Root Cause Analysis
Quality Investigations
Corrective Actions
Preventative Actions
Sterile Manufacturing
Cell Therapy
Quality Oversight
Legend Biotech
Develops and commercializes cell therapies
About Legend Biotech
Legend Biotech develops and commercializes 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 cells to combat cancer. Legend Biotech emphasizes transparency with investors, regularly updating them on financial results and business developments.
Franklin Township, New JerseyHeadquarters
2014Year Founded
$146.4MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
1,001-5,000Employees
Benefits
Health Insurance
Dental Insurance
Vision Insurance
Life Insurance
Disability Insurance
Paid Sick Leave
Paid Holidays
Remote Work Options
Risks
Increased competition from Amgen's Imdelltra may impact CAR-T therapy focus.
Collaboration with Multiply Labs may face technological challenges, delaying production timelines.
Financial strain from new R&D facility could affect operational focus if advancements lag.
Differentiation
Legend Biotech focuses on novel cell therapies for oncology, including CAR-T and NK cells.
The company is technology agnostic, exploring multiple platforms for effective cancer treatments.
Legend Biotech's CARVYKTI® is the first BCMA-targeted CAR-T therapy approved for second-line use.
Upsides
Recent FDA and European approvals for CARVYKTI® expand its market reach in multiple myeloma.
New R&D facility in Philadelphia boosts innovation in next-generation cell therapies.
Alan Bash's appointment could accelerate CARVYKTI®'s growth and market penetration.
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