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[北京]百济神州(北京)生物科技有限公司
职位:QC Specialist (MJ022259)
发布时间:2026-06-22
工作地点:北京
信息来源:前程无忧(51JOB)
职位类型:全职
职位描述
专业1:分析化学
专业2:药学
职能类别:质量工程师
General Description:
Reporting to the Beijing site QC Lead, executes analytical tests as assigned tasks. In this role, participate GMP QC related activities which are contributing to business objectives. This individual must have a basic understanding of GMP, internal guidance, Data Integrity principle and the routine lab processes, an in-depth understanding of analytical technologies.
执行指定的分析检测任务,向北京公司质量控制负责人汇报。此角色将参与有助于实现业务目标的GMP 质量控制相关活动。对GMP、国际指导原则、数据可靠性原则和常规实验室流程有基本了解,对分析技术有深入的了解。
Essential Functions of the job:
1. Operate the common analytical equipment independently, such as HPLC, UV-Vis, IR, KF, Dissolution etc.
独立操作常用的分析设备,比如高效液相、紫外、红外、水分仪、溶出仪等。
2. Conduct routine monitoring of purified water system, clean room air system and cleaning verification, of production equipment.
对纯化水系统、洁净室空调系统进行日常监控,执行生产设备的清洁确认。
3. Perform sampling and complete tests for in-coming materials (API, excipient, pack component).
对来料(原料,辅料,包装材料)执行取样和检测。
4. Finish release tests for GMP clinical batches and stability tests per stability protocol.
完成GMP临床批次的放行检测并参照稳定性方案完成稳定性检测。
5. Conduct method validation activities per method validation/transfer protocol.
根据方法验证/转移方案完成方法验证活动。
6. Complete test records per Good Documentation Practice.
按照良好记录规范要求完成检测记录。
7. Understanding QC SOP/SPEC, review and update SOP/SPEC as required.
理解质量控制相关的操作规程和质量标准,根据需要审核和更新操作规程和质量标准。
8. Participate qualification, calibration and maintenance of the analytical equipment.
参与分析仪器的确认、校准和维护。
9. Manage reference standards and stability samples.
管理标准品和稳定性样品。
10. Accomplish the required initial and continuing training for quality personnel.
完成质量人员必需的入职培训和更新性培训。
11. Draft stability report or other technical reports.
起草稳定性报告或其他技术报告。
12. Contact contract vendor for samples, external testing and the relevant data pack.
就样品、外部检测和相关数据包联系合同供应商。
13. Other duties as assigned by superior.
上级交予的其它工作。
?
Education Required:
Master degree or above, Major in pharmacy, analytical chemistry or related
硕士及以上学历,药学、分析化学或相关专业
Competencies:
Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
道德:尊重他人, 诚实可靠;工作中能坚守正义和道德,支持企业价值观。
Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently.? Completes administrative tasks correctly and on time.? Follows instructions and responds to management direction.
规划/组织 : 确定工作活动的优先顺序和计划,能够有效地利用时间。 正确、准时地完成上级布置的任务, 遵循指示并响应管理方向。
Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations.? Writes clearly and informatively.? Able to read and interpret written information.
沟通:懂得聆听他人意见以及清楚表达自己的观点;在任何情况下都要表达清楚,且有说服力。所写内容要清楚明了,内容翔实。能够阅读并理解书面内容。
Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed.? Contributes to building a positive team spirit; Shares expertise with others.
团队合作 – 能够平衡团队和个人地责任; 能够给予他人反馈并接受他人反馈; 有助于建立积极的团队精神; 将团队的成功置于个人利益之上; 支持团队中每个人的努力。 有助于建立积极的团队精神; 与他人分享专业知识。
Adaptability – Able to adapt to changes in the work environment.? Manages competing demands.? Changes approach or method to best fit the situation.? Able to deal with frequent change, delays, or unexpected events.
适应性:能够适应工作环境中的变化。管理竞争需求,能够根据不同情况改变方法或者方式。能够应对频繁的变更、延期和突如其来的情况。
Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.
技术技能 – 能够评估自己的优势和发展领域; 追求培训和增长机会; 不断努力丰富自己的知识和打造自己的技能;能与他人分享专业知识。
Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
可靠性 – 能遵循指示,响应管理方向;对自己的行为负责; 遵守承诺; 为完成目标,必要时可接受长时间的工作,按时完成工作或根据备用计划通知合适的员工。
Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
工作质量 - 表现出准确性和彻底性; 寻找改善和提升质量的方法; 应用反馈以提高性能; 监督自己的工作以确保质量。
Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.
分析能力-能够简化复杂或者多样的信息;收集和研究数据;依靠直觉和经验来补充数据
Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.
问题解决能力-能够及时地找出问题并解决问题;能够有技巧地收集并分析信息。
Project Management - Communicates changes and progress; Completes projects on time and budget.
项目管理-能够沟通变化和进展,能够在预算范围内及时地完成项目。
Computer Skills:
Proficient in computer skills including Outlook, Word, Excel, and PowerPoint, etc.
熟练掌握计算机技能,包括操作Outlook,Word,Excel,and PowerPoint等办公软件。
Other Qualifications: ??
Capability of arranging and completing tasks per priority
具备按优先级别安排和完成任务的能力
Ability to communicate well within and across teams
具备良好的团队沟通和跨部门沟通能力
English: fluent in writing and speaking
英语水平:口语和书面表达流利
Travel:?
Travel is required if necessary
必要时需要出差
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"、"***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 ***, 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.
公司简要介绍:
公司名称:百济神州(北京)生物科技有限公司
公司类型:外资(欧美)
公司规模:10000人以上
公司介绍:百济神州成立于2010年,是一家全球肿瘤治疗创新公司。作为创新药全球化领导者,我们自创立以来,秉承"百创新药 济世惠民”的愿景,立志成为医药生态圈的变革者,以国际化的发展理念,引领生物医药行业模式的转型,力求为全世界的癌症患者带来可及与可负担的创新药物。
百济神州积极致力于为患者和社会带来深远影响。为此,我们率先建立起创新的全球运营模式,构建了强大的差异化科研能力、广泛的临床开发布局、规模化的自主生产能力,以及基于科学的多元商业化策略。随着全球业务的发展,我们已经在六大洲打造了一支超过11,000人的团队。目前,百济神州在美国纳斯达克、中国香港联交所和上交所科创板三地上市。
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