Quality Assurance Specialist

6 days ago


Piscataway, New Jersey, United States GenScriptProBio Full time
About GenScript/ProBio

GenScript/ProBio is a global biotechnology group with a strong presence across North America, Europe, the Greater China, and Asia Pacific. Founded in 2002, the company has established itself as a leading provider of gene synthesis technology and biologics development and manufacturing services.

ProBio's Mission

ProBio is committed to accelerating drug development for customers through its end-to-end CDMO service from drug discovery to commercialization. The company's total cell and gene therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing.

Job Scope

We are seeking a talented Quality Assurance Specialist to join our team. The successful candidate will be responsible for establishing and maintaining a quality management system, supervising and promoting the implementation of the system, and performing release of raw materials and final products.

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.


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