QC技术员-微生物 at Eli Lilly in Suzhou, Jiangsu, China

QC技术员-微生物 Location: China, Suzhou Manufacturing-苏州工厂 At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. 实验室测试与合规 | Laboratory Testing & Compliance 参与微生物实验室的日常测试工作，确保所有检测活动符合中国 GMP 要求及礼来 GQS 要求。 Participate in routine microbiological laboratory testing and ensure all testing activities comply with China GMP and Lilly GQS requirements. 执行微生物实验室的放行测试，包括但不限于：公用系统（水系统）、中控样品、原辅料、包材、稳定性样品及成品。 Perform QC microbiological release testing, including but not limited to utilities (water systems), in‑process controls (IPC), excipients, primary packaging components (PPC), stability samples, and drug products. HSE 与数据完整性 | HSE & Data Integrity 严格遵守 HSE 规程，在日常工作中正确穿戴及使用个人防护装备（PPE）。 Strictly comply with HSE procedures and correctly wear and use personal protective equipment (PPE) during daily work. 在所有实验室活动中严格遵守数据完整性（DI）相关要求。 Ensure full compliance with data integrity requirements during all laboratory activities. 积极在团队内及跨团队分享质量和安全相关事项。 Proactively share quality‑ and HSE‑related events within the team and across functions. 方法、文件与体系 | Methods, Documentation & Quality System 协助微生物实验室相关方法的确认与研究，包括方案起草、实验执行及验证/研究报告撰写。 Support method verification and studies for microbiological testing, including protocol drafting, execution of verification activities, and generation of verification/study reports. 负责微生物测试相关 WI 和 SOP 的起草、修订与维护。 Be responsible for drafting, revising, and maintaining WIs and SOPs relevant to microbiological testing. 参与微生物实验室文件管理工作。 Participate in documentation management for the microbiological laboratory. 实验室管理 | Laboratory Management 参与微生物洁净室的日常管理。 Participate in microbiological cleanroom management. 参与微生物检测相关的消耗品、试剂以及全球/本地标准品的管理。 Participate in the management of consumables, reagents, and global/local reference standards related to microbiological testing. 参与微生物实验室 5S 管理活动。 Participate in 5S management activities within the microbiological laboratory. 系统、持续改进与其他 | Systems, CI & Others 协助 GLIMS实施。 Support GLIMS deployment. 参与实验室质量体系的持续改进并支持 GLIMS 的实施与优化。 Support continuous improvement of the laboratory quality system and GLIMS implementation. 执行其他与质量相关的工作任务。 Perform other quality‑related tasks as assigned. 可选职责 | Optional Responsibilities 负责稳定性样品的接收和取样。 Be responsible for the receiving and sampling of stability samples. 负责实验室日常检测报告的第二人复核。 Perform second‑person review of routine laboratory reports. 负责实验室新员工/新分析员的培训。 Provide training to newly hired analysts. 工作安排 | Work Arrangement 该岗位可能需要轮班工作，包括早班、中班及周末。 This position may require shift work, including morning, middle shifts, and weekends. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. #WeAreLilly