QA Operations Lead

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:

The QA Operations Lead role is to ensure that end-products are meeting quality pre-established standards, through inspecting and monitoring both products, procedures and processes.

Reporting to: QA Sr Manager

Key Responsibilities:

• Investigating any non-conformity or complaints and taking corrective measures.

• Monitoring procedures, analyzing issues, and reporting any repetitive problems.

• Performing routine GEMBA walks in production are and identify opportunities of improvement.

• Inspecting and releasing outgoing products.

• Implementing and optimizing processes to ensure that products consistently or exceed established quality standards.

• Participating in the Internal Audits of QMS per the established annual schedule

• Participating in the vendors qualification program.

• Providing proper methods for reporting.

• Other quality related tasks as assigned.

Qualifications

• Bachelor's degree in the scientific discipline of molecular biology, chemistry, biochemistry, pharmaceutical science, chemical engineering or related field.

• 5+ years of relevant experience in Quality Assurance or Quality Control experience in a ISO9001 or GMP manufacturing environment will be prioritized.

• Excellent written and verbal communication skills with internal and external customers, peers and managers.

• Individual may be required to sit, stand, walk regularly in production are, and occasionally lift 0-15 pounds.

#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.