Quality Assurance Specialist
1 month ago
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.
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