QC实习生

岗位职责 / Responsibilities

1. 在带教导师指导下，严格按照标准操作规程（SOP）开展纯化水、注射用水及纯蒸汽冷凝水的检测，并规范、完整地填写检验记录。

Under the guidance of a mentor, strictly follow standard operating procedures (SOPs) to testing of purified water, water for injection and pure steam condensate, and complete test records in a standardized and complete manner.

2. 按照标准操作规程开展原辅料的取样、鉴别与检测，协助完成物料放行相关的数据整理与台账维护。

Carry out sampling, identification and testing of raw materials and excipients in accordance with SOPs, and assist in data compilation and record maintenance related to material release.

3. 参与抗体及ADC产品的理化与生化检测，学习并实践原液、中间体及成品的质量分析方法。

Participate in the physicochemical and biochemical testing of antibody and ADC products, and learn and practice quality analysis methods for drug substance, intermediates and finished products.

4. 协助准备审计资料，参与官方审计及合作伙伴审计的现场迎检工作，深入了解GMP合规要求。

Assist in preparing audit documentation and participate in on-site activities for official and partner audits, gaining in-depth exposure to GMP compliance requirements.

5. 参与OOS/OOT等检验异常与偏差的调查，学习根本原因分析与CAPA的基本思路和方法。

Participate in the investigation of OOS/OOT and other abnormal or deviating results, and learn the fundamentals and approaches of root cause analysis and CAPA.

6. 按照标准操作规程完成实验室仪器的日常维护与状态确认，参与实验室现场管理及5S工作。

Complete routine maintenance and status verification of laboratory instruments in accordance with SOPs, and participate in on-site laboratory management and 5S activities.

7. 完成带教导师及直接主管交办的其他工作。

Complete other tasks assigned by the mentor and the line manager.

任职要求 / Requirements

1. 本科及以上在校学生，生物化工、制药工程、分析化学等相关专业优先。

Currently enrolled undergraduate or postgraduate student; majors in biochemical engineering, pharmaceutical engineering, analytical chemistry or other related disciplines are preferred.

2. 具备良好的实验操作规范意识与动手能力，能够准确、完整地记录并整理实验数据。

Demonstrate solid laboratory practice awareness and hands-on skills, and be able to record and organize experimental data accurately and completely.

3. 具备扎实的生物与化学基础知识储备，工作细致严谨，能够胜任精细度要求较高的实验室检测工作。

Possess a solid foundation of knowledge in biology and chemistry, work with care and rigor, and be capable of performing laboratory testing that demands a high level of precision.

4. 综合条件优异者，相关任职要求可适当放宽。

Requirements may be relaxed for candidates with outstanding overall qualifications.

5. 每周到岗至少3天，实习周期可结合课程安排协商确定。

Able to work on-site at least 3 days per week; the internship duration can be discussed and arranged around the academic schedule.