聂洁敏

Self-assessment

1 An studious worker and always embrace change positively.

2 Careful and responsible working attitude, able to take the initiative to take on tasks and pay attention to every detail.

Familiar with the whole process of chemiluminescent products from design transfer to complete registration.
Konw well the production process and release test methods of chemiluminescence products.
Familiar with the traceability system and value assignment methods of calibrators and quality controls.
Experienced in handling technical problems occurred in the production process and customer complaints.
Familiar with risk management of products, especially in design and process risk analysis.
Acquainted with the validation of critical process parameters and can utilize DOE tools to complete the related work.
Know well how to design experiments of raw material replacements evaluation for IVD reagents.
Familiar with the Chinese GMP requirements.
Acquainted with the process of non-conformance, temporary deviations, changes, and CAPAs in the quality management system and have the experience to deal with related problems.
Familiar with various guidelines and standards related to in vitro diagnostic reagents.
molecular cloning and protein purification
Proficient in molecular cloning, gene sequencing, protein separation and purification (SDS-PAGE), protein content determination (BCA), and DOE experimental design.
software skills
Proficient in software operation, including Office, MiniTab, DNAMAN, DNASTAR, Primer 6.0, etc.

Projects

Companies