QA Specialist
Requires strong biology background. The QA specialist will perform under department SOPs and regulations, ensure the quality of the services and productions, and avoid issues happened by human error in production. Conducting quality assurance of all products and documents provided to customer by supervisor’s instruction. Responsible for ensuring that the laboratory regulations are met, helps establish and maintain procedures and processes to ensure regulatory compliance and helps the regulatory function to provide support to enable launch new products. This position also may assist in the SOP optimization and reporting violations of regulations to director.
Key Responsibilities
- Perform QA process of all products, ensuring all products meet quality criteria before delivering
- Double check final products/documents, eliminate any issues caused by human error in production
- Determine, negotiate and agree on gene-synthesis, plasmid prep and other production quality procedures, standards and specifications
- Optimize bench work standards for all positions in the lab
- Work with lab technicians/ associate scientists to establish procedures, standards, system and determine training needs
- Record, analyze and distribute statistical information based on daily observation, work with production team closely and report to lab manager on any violation of SOPs
- Perform and document corrective action, including follow-up monitoring to gauge effectiveness of the corrective action
- Maintain laboratory permits by completing and filing annual renewal applications for various regulatory agencies, manage warranty of laboratory equipment
- Track and monitor bench work performance through review of quality control data and close supervision
- Tracking and maintenance of staff quality records for performance review
- Other quality assurance duties assigned by supervisors
Experiences & Skills
- B.A./B.S. in Biology or related science, Master's Degree is preferred
- Bilingual in Mandarin and English speaking is preferred
- Laboratory experience is preferred
- 1 year industry experience working as QA specialist would be a plus
- Strong communication, organizational, and time management skills.