QC TechnicianⅡ

, complete required safety trainings and emergency drills; promptly report any safety incidents, accidents, or potential hazards;

7. 07

   其他管理层安排的任务 Other Assignments 完成管理层安排的其他工作。 Perform other tasks assigned by management. 工作要求 Job Requirements 大专及以上学历，化学、药学、生物、分析相关专业 College degree or above in Chemistry, Pharmacy, Biology, or related fields A. 专业与合规能力 Professional & Compliance 掌握 QC 理化检测的基本操作和常用分析仪器（如 pH 、导电率、天平等）；了解环境监测（ EM ）的原理、采样要求、警戒限 / 行动限；了解并遵守 GMP 以及 FDA / EMA （含 Annex 1 ）相关法规要求；能在授权范围内独立执行理化检测和环境监测活动。 Possess a solid understanding of the basic operations of QC physicochemical testing and common analytical instruments, such as pH meters, conductivity meters, and balances; Know the principles of environmental monitoring (EM), including sampling requirements, alert/action limits; Understand and comply with GMP requirements as well as relevant FDA and EMA regulations, including Annex1; Be able to independently perform physicochemical testing and environmental monitoring activities within the approved scope of authorization. B. 数据完整性与记录规范 Data Integrity & Documentation 理解并执行数据完整性原则（ ALCOA+ ）；按要求进行纸质和电子原始记录，确保数据真实、完整与可追溯；理解审计追踪（ Audit Trail ）基本要求，并配合数据复核和审计活动；能使用实验室相关系统（如 LIMS、 EM 记录系统及仪器软件）。 Understand and comply with data integrity principles (ALCOA+); Create and maintain paper-based and electronic raw records as required, ensuring data accuracy, completeness, and traceability; Understand the basic requirements of audit trails and cooperate with data review and audit activities; Be able to use laboratory-related systems (such as LIMS, environmental monitoring record systems, and instrument software). C. 学习与协作能力 Learning & Collaboration 具备学习能力，能在培训后承担理化检测、环境监测与微生物检测；能与微生物组、 QA 、生产等部门进行有效沟通与协作。 Demonstrated ability for learning, capable of undertaking physicochemical testing, environmental monitoring, and microbiological testing after training; Able to communicate and collaborate effectively with the Microbiology team, QA, Production, and other relevant departments. 具备基础英文阅读能力，可理解检测方法、 SOP 和技术文件；了解办公软件及实验室相关系统的使用。 Possess basic English reading skills and be able to understand analytical methods, SOPs, and technical documents; Understand the use of office software and laboratory-related systems. 百济神州全球胜任力 当我们通过以下十二项全球胜任力，展现出 "患者为先"、"无界协作"、"锐意创新 "和 "追求卓越 "的价值观时，我们就能帮助全世界更多患者获得更多负担得起的药品。 ●团队协作 ●提供并征求坦诚及可行的反馈 ●自我认知 ●兼容并蓄 ●积极主动 ●开拓精神 ●持续学习 ●拥抱变化 ●结果导向 ●分析性思维/数据分析 ●卓越财务 ●清晰沟通 BeOne Global Competencies When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. ●Fosters Teamwork ●Provides and Solicits Honest and Actionable Feedback ●Self-Awareness ●Acts Inclusively ●Demonstrates Initiative ●Entrepreneurial Mindset ●Continuous Learning ●Embraces Change ●Results-Oriented ●Analytical Thinking/Data Analysis ●Financial Excellence ●Communicates with Clarity 求职者隐私申明： 百济神州致力于尊重和保护您的个人信息权利，并承诺依据合法、正当、必要和诚信的原则处理您的个人信息（包括个人敏感信息 ）。 由于百济神州在全球范围内开展业务，我们可能需要基于人力资源管理等合理业务目的而将您的个人信息发送和/或存储在位于您所在国家以外其他国家（例如：美国）的服务器和数据库中，详情参见百济神州《求职者隐私政策》（百济神州官网 - 隐私政策 - 求职者隐私政策）。 如您主动向我们提供您的简历信息或其他个人信息，则视为您已经充分理解并确认接受百济神州《求职者隐私政策》内容。如您对此有任何疑问的，请勿提交简历信息或其他个人信息。 BeOne is committed to respect and protect your personal information rights, and will process your personal information, including your sensitive personal information, based on the principles of legality, legitimacy, necessity, and integrity. Due to the reasonable business need for human resource management as a result of BeOne’s global operation, your personal information may be transferred and/ or stored in a server/database located in a third country (e.g., the United States) other than your own country. For further details, please refer to BeOne Job Applicant Privacy Policy (BeOne official website - Privacy Policy - Job Applicant Privacy Policy). If you voluntarily provide your resume or other personal information to us, it is deemed as you have thoroughly acknowledged and accepted BeOne Job Applicant Privacy Policy. If you have any concern, please DO NOT submit your resume or any other personal information.

in compliance with regulatory requirements, ensuring data integrity, compliance, and reliability of QC results. 主要职责 Main Roles

1. 01

   按经批准的 SOP 、方法和个人培训授权范围，开展理化和 / 或微生物相关的取样和检测，包括但不限于： Perform physicochemical and/or microbiological sampling and testing within the scope of approved SOPs, test methods, and individual training authorization, including but not limited to: a) 取样 Sampling 负责实验室测试样品的取样，包括原辅包、成品和公用设施样品。 Be responsible for sampling laboratory testing samples, including raw materials, finished products and utility systems samples. b) 理化检测 Physicochemical Testing 负责原辅料、成品、稳定性样品及相关公用系统样品的理化检测；正确使用并维护理化分析仪器，确保其在受控状态下运行；准确、完整、同步地记录所有测试活动、原始数据、计算和结果，以确保完全的可追溯性和数据可靠性。 Be responsible for the testing of raw materials, excipients, finished products, stability samples, and relevant utility system samples; Properly operate and maintain physicochemical analytical instruments to ensure they remain in a controlled and qualified state; Accurately, completely, and contemporaneously record all test activities, raw data, calculations, and results to ensure full traceability and data reliability. c) 公用系统监测 Utility Monitoring 负责洁净区空气、表面、人员及设施等的环境监测；按 SOP 要求进行采样、培养、计数和结果记录；及时识别并上报任何超出警戒限或行动限的环境监测结果；支持环境监测数据的汇总和趋势分析，以识别潜在风险并支持持续改进。 Be responsible for the monitoring of cleanroom air, surfaces, personnel, and facilities; Conduct sampling, incubation, enumeration, and result recording in accordance with SOP requirements; Promptly identify and report any environmental monitoring results exceeding alert or action limits; Support the compilation and trend analysis of environmental monitoring data to identify potential risks and support continuous improvement. d) 支持微生物检测 Support Microbiological Testing 在完成相关培训并获得授权后，协助微生物测试组开展已批准的微生物检测操作，如样品准备、培养、计数和记录；确保微生物测试支持活动符合批准的程序、无菌技术和数据完整性要求。 After completion of relevant training and authorization, assist the microbiology testing team in performing approved microbiological testing activities, such as sample preparation, incubation, enumeration, and documentation; Ensure microbiological testing support activities comply with approved procedures, aseptic techniques, and data integrity requirements. e) 参与本岗位分析方法验证 / 确认 / 转移的执行。 Participate in the implement of method validation/verification/transfer. f). 在授权范围内开展实验记录的复核，包括审计追踪。 Review the experimental records within the authorized scope, including audit trails.

2. 02

   偏差 /OOX/ 实验室异常事件调查 Deviation/OOX/Lab event investigation 在授权范围内协助理化检测和 / 或环境监测相关偏差、 OOX 和实验室异常事件的调查；如实提供监测数据和实验信息；根据调查策略执行调查，并执行纠正与预防措施（ CAPA ）。 Participate, within the authorized scope, assit in the investigation for deviations, OOX, and lab evevts related to physicochemical testing and environmental monitoring; Provide test data and experimental information truthfully and accurately; Conduct the investigation in accordance with the investigation strategy and implement corrective and preventive actions (CAPA).

3. 03

   CAPA 与变更控制 CAPA & Change Control 为变更影响评估、验证 / 确认策略的制定与实施提供支持，以确保合规和按期关闭。 Support change impact assessment and validation/qualification strategies and execution to ensure compliant, traceable, and timely closure.

4. 04

   数据完整性与合规 Data Integrity & Compliance 严格遵守数据完整性（ ALCOA+ ）和公司记录管理要求；根据需要支持内部 / 外部 GMP 审计与检查准备，包括数据抽查、审计追踪检查和培训符合性检查；及时报告任何潜在的数据完整性或合规风险。 Strictly comply with data integrity (ALCOA+) principles and company record management requirements; support internal/external audits and inspection readiness, including data sampling, audit trail check, and verification of training compliance; promptly report any potential data integrity or compliance risks.

5. 05

   文件、培训与持续改进 Documentation, Training & Continuous Improvement 支持本岗位理化检测和环境监测相关 SOP 、记录模板和操作文件的起草、修订与培训；按年度计划完成 GMP、数据完整性、理化、环境监测及微生物相关培训；持续提升专业能力和合规意识，支持实验室持续改进。 Support the drafting, revision, and training of SOPs, record templates, and operational documents related to physicochemical testing and environmental monitoring; Complete GMP, data integrity, physicochemical testing, environmental monitoring, and microbiology-related training according to the annual training plan; Continuously enhance professional competence and compliance awareness to support ongoing laboratory improvement.

6. 06

   EHS 严格遵守实验室 EHS 要求和安全操作规程，落实个人安全职责，完成岗位必须的安全培训与应急演练；及时报告任何安全事件、事故或潜在危险。 Strictly comply with laboratory EHS requirements and safety operating procedures; uphold personal safety