Quality Assurance Specialist
OkloSalary not specified
Full Time
Junior (1 to 2 years)
Not SpecifiedCompensation
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 4 years relevant work experience (preferable in aseptic manufacturing facility, quality assurance, manufacturing compliance, clinical quality, or cell therapy)
- Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices
- 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
- Good written and verbal communication skills
- Ability to summarize and present results, and experience with team-based collaborations
- Ability to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk
- Strong leadership skills and ability to effectively develop others
- Ability to collaborate well with stakeholders, customers and peers
- Strong decision-making ability and think creatively while maintaining compliance and quality
- Ability to discern the criticality of issues and communicate to management regarding complex issues
- Ability to manage conflict and issues that arise with internal or external customers
Responsibilities
- 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 manufacturing issues
- Ensure accurate and timely maintenance and review of manufacturing investigations, CAPAs, change controls and complaints
- Review and approve manufacturing procedures
- Support regulatory inspections and audits by ensuring inspection readiness within facility
- Perform internal housekeeping audits
- Perform analysis on quality indicating data and identifying trends
- Provide oversight for trending of quality compliance metrics
- Provide quality oversight over the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment
- Support and approve manufacturing investigations
- Ownership of various department projects
- Tracking of quality metrics while ensuring high quality and compliant product supply
- Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals
- Works in a collaborative team setting with quality counterparts that include Manufacturing Operations, Operations Technical Support, Maintenance, Supply Chain and Planning
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
What is the location for this QA Investigations Lead III role?
The position is based in Raritan, NJ.
What are the minimum education and experience requirements?
A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline and 4 years of relevant work experience are required.
What key skills or knowledge are needed for this position?
Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products, along with experience in aseptic manufacturing facilities preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy is required.
What is the work environment like for this role?
The role works in a collaborative team setting with quality counterparts including Manufacturing Operations, Operations Technical Support, Maintenance, Supply Chain and Planning, in a sterile GMP environment with routine exposure to biological materials and hazardous chemicals.
What makes a strong candidate for this QA Investigations Lead III position?
Candidates with experience in an aseptic manufacturing facility, particularly in quality assurance, manufacturing compliance, clinical quality, or cell therapy, stand out.
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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