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The Senior QC Engineer is responsible for the QC aspects of the KC project. He/She will receive methods from the overseas factory, adapt and establish them at the Tonglu site, and perform method verification and qualification. After project completion, he/she will be responsible for the inspection and release of materials and finished products.
Job Responsibility
Perform testing and release of experimental samples, finished products, and raw materials
Conduct routine physicochemical testing, microbiological limit testing, and endotoxin testing in accordance with approved procedures
Accurately record, review, and report test results, ensuring data integrity and traceability
Support the maintenance of the laboratory quality management system, including participation in deviation, OOS, and change control activities
Operate, maintain, and document the use of laboratory instruments and equipment
Assist with internal and external audits and inspections as required
Requirements
Bachelor's degree or above in Biology, Pharmaceutical Sciences, Chemistry, Testing & Inspection, or related fields
Hands-on experience or solid knowledge of physicochemical, microbiological, and endotoxin testing
Familiarity with GMP and laboratory quality standards is preferred
Strong sense of responsibility, attention to detail, and quality awareness
Good communication skills and ability to work effectively in a team
Proficiency in written and spoken English
able to read, understand, and prepare technical documents and SOPs in English
Willing and able to stay at the Sweden site for 2–4 weeks to support project needs
Nice to have
Familiarity with GMP and laboratory quality standards