QA Specialist

4 weeks ago

Piscataway, New Jersey, United States GenScript Full time

About GenScript

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

About GenScript ProBio

GenScript ProBio is the subsidiary of GenScript Biotech Corporation, proactively providing 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. GenScript 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, GenScript 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, GenScript ProBio has a stable and high-yield viral vector platform.

Job Scope:

We are looking for a talent who is proficient in quality management to help the business department with incoming material control, on-site quality monitoring, quality data analysis and product release. it is crucial for this role to understand the basic principles of quality management, be familiar with the production process, adhere to the principles, and have good communication and coordination skills. it is best to have rich experience in biotechnology or quality systems and will work closely with the production department and back-end support department.

Key Responsibilities:

Establish and maintain a quality management system, supervise and promote the implementation of the system.
Perform release of raw materials and final products.
Timely discover on-site problem/hidden danger through daily supervision and ensure timely rectification of problem/hidden dangers through communication and coordination to improve on-site 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 quality-related training.
Other quality related tasks as assigned.

Qualifications
Bachelor's or Master's degree in biology, Chemistry, Pharmacy, Medicine and related majors.
2+ years of production or quality related work experience, have relevant knowledge on quality management.
Strong verbal and communication skills.
Excellent interpersonal and teamwork skills required to work effectively and efficiently in a team-based environment.
Ability to multi-task in a dynamic environment with changing priorities.

#GS
#LI-LW1 GenScript USA Inc/GenScript ProBio USA Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.
GenScript USA Inc./GenScript ProBio USA Inc. maintains a drug-free workplace.

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