Specialist, QC Activity
Be responsible for the daily detection of biological activity, protein A residue and host cell protein residue of laboratory samples, and ensure the timely and effective completion;
Solve technical problems in the application of analytical methods;
Report the deviations and OOS occurred in the experimental test, participate in the investigation and the implementation of CAPA;
Be familiar with GMP regulations, organize the writing of SOP, validation protocol and validation report of analytical methods;
Be responsible for the maintenance of laboratory instruments and meters,and the drafting and review of relevant SOPs. If necessary, be responsible for the 3Q verification of laboratory-related equipment;
Participate in the activity analysis of product stability research and write stability research reports;
Participate in the compliance management of the active analysis group;
Actively complete other work tasks delivered.
Identify the corporate culture of the company and be enterprising and responsible for the job;
Bachelor degree or above, major in biochemistry, drug analysis, biotechnology, analytical chemistry and other related specialties;
Bachelor degree requires at least three-year experience in biological pharmaceutical activity testing, and Master degree requires at least one year experience in biological pharmaceutical activity testing;
Proficient in ELISA and cell activity detection skills;
Has strong experimental operation ability, strong hands-on ability, and be serious and responsible for work;
Proactive work and a strong sense of responsibility. Have a good team spirit and communication ability;
Good English writing and reading ability.