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Quality Assurance (QA) Engineer

Min Experience

2 years

Location

Piscataway, New Jersey

JobType

full-time

About the job

Info This job is sourced from a job board

About the role

Establish and maintain a quality management system, supervise and promote the implementation of the system Perform release of raw materials and final products Timely discovery of onsite problems / hidden dangers through daily supervision, and ensure timely rectification of problems and hidden dangers through communication and coordination to improve onsite quality management levels Participate in the investigation and handling of product complaints, returns, and substandard products and materials. Responsible for quality-related data collection and statistical work, timely feedback on quality information and regular analysis reports Tracking deviation, OOS, change investigation and CAPA tracking confirmation Responsible for delivering quality related trainings

About the company

GenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy. GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology. ProBio proactively provides end-to-end CDMO service from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in cell and gene therapy (CGT), vaccine, biologics discovery and antibody protein drug to accelerate drug development for customers. ProBio's total cell and gene therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing. In terms of plasmid service, ProBio supports the most clinical approvals for CGT drugs including mRNA vaccines, CAR-T in China. It is also the first GMP manufacturing platform to provide in vitro transcription (IVT) template linearized plasmids for mRNA vaccines and has supported several mRNA vaccine global enterprises to obtain clinical approvals. In terms of viral vector service, ProBio has a stable and high-yield viral vector platform.

Skills

quality management
quality assurance
product release
data analysis
quality training