Scientist, Quality System

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Job description

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 ProBio

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.

Job Scope:

Contributes to the on-going enhancement of ProBio's quality systems by supporting Good Manufacturing Practices (GMP) quality management systems for both clinical and commercial Cell and Gene Therapy products. This role involves working with cross-functional internal teams, customers, and external resources (when required) to ensure compliance to internal and external quality systems.This individual is responsible for providing quality support to change controls, deviations, investigations, lab investigations and Corrective and Preventive Action (CAPA) related to Cell and Gene Therapy Manufacturing and Support.The incumbent supports adherence to relevant regulatory requirements, company Standard Operating Procedures (SOPs), as appropriate, and works cross-functionally to improve GxP Quality and Compliance.

Essential responsibilities:

• Supports ProBio Inc. and external Quality Management Systems to achieve and maintain GxP compliance with worldwide manufacturing regulations, guidelines, and current regulatory requirements for both clinical and commercial Cell and Gene Therapy products manufactured and/or tested at the Hopewell, NJ facility.
• Performs Quality Assurance (QA) review and approval of documentation related to Change Control, Corrective and Preventative Action (CAPA), Deviations, Laboratory Investigations, incidents, complaints, exceptions, and Out of Specification (OOS) reports as generated by ProBio Hopewell, NJ facility in accordance with current QA procedures.
• Supports ProBio internal team members with Root Cause Analysis and Investigations. Drives completion of Investigations and CAPAs as needed.
• Performs other tasks and assignments as needed and specified by management.

Qualifications:

• Bachelor's degree in a scientific discipline and a minimum 3 years of experience in QA or related role(s) in a pharmaceutical, biotechnology or related environment, and at least 1 of which have been in a CMC-focused QA position.
• Demonstrated experience with GxP document management systems and/or other QMS (e.g. Veeva QualityDocs, Veeva QMS, TrackWise QMS etc.).
• In-depth knowledge of quality risk management, Root Cause Analysis, and appropriate investigation tools.
• Demonstrated understanding biologics manufacturing and laboratory activities.
• Demonstrated knowledge and understanding of business practices and procedures associated
• with GxP Document Control, Change Control, CAPA, Deviation, and/or Lab investigations.
• Detailed knowledge and understanding of GMP regulations and compliance regulatory requirements.
• Demonstrated ability to communicate proactively with a positive customer service attitude.
• Proficiency with Microsoft Office.
• Excellent verbal and written communication skills.
• Ability to work virtually, independently, and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.

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GenScript USA Inc/ProBio 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./ProBio Inc. maintains a drug-free workplace.

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