1. 领导并管理微生物团队进行相关微生物测试（无菌，GPT， 生物负载， 微生物限度， AME/PET测试等）。
Lead and manage the Micro team for the execution of the microbiological testing (Sterility, GPT, Bio-burden, )Microbial Limits, AME/PET testing, etc...)
2. 负责调查超限/OOS/NC 并找到根本原因；负责CAPA的发起及相应的行动项的跟进。做到及时、准确，逻辑清晰、能够提供行之有效的纠正预防措施。负责相关变更的发起、追踪与关闭。
Be responsible for the Excursion/OOS/NC investigation to find out the root cause; Be responsible for the CAPA initiation and related activities follow up. Ensure the investigation performance detailed and specific with logistic, as well as the CAPA effective. Be responsible for related Change Request initiation, tracking and closure.
Be responsible for media fill simulation process inspection, and also be responsible for guiding and inspecting the media fill products' sterility check.
Assist manager to make the training plan for laboratory employees according to testing needs, perform the technical coach for new employees and make sure that the operation skills of new employees comply with GMP/EHS requirements.
Be responsible for the validation in micro lab, such as equipment validation, method validation, method suitability verification, disinfectant validation etc.
Be responsible for related assessment in micro lab, completed the assessment and suggest the action plans accordingly, e.g. assessment for Pharmacopoeia revision, assessment for regulation update and assessment for local procedure according to global procedure update.
In charge of micro lab operation excellence and continuous improvement; optimize lab workflow; improve lab working efficiency.
In charge of micro lab EHS&S management. Follow up JNJ policy of EHS strictly, as well as Production Safety Law and relevant local regulations on the post safety responsibilities. Follow up procedures and work instruction, correctly use PPE and participate training. Contribute to continuous improvement the EHS working process of QC to eliminate potential risk.
9. 遵循ISO13485，GMP，21CFRPart 820，21CFRPart 211及公司政策，符合规定的要求，协助经理进行各种审计准备。
Comply with the requirements of ISO13485, GMP, 21CFRPart 820, 21CFRPart 211 and company regulation, assist manager in audit preparation.
Perform other management responsibilities such as lab budget establishment, financial data statistics, project related expense & labor hours statistics and training coordinate etc.
Executing management responsibilities for the direct report staffs, including performance review and talent development, associated with training, monitoring, coaching for these direct report staffs.
Good communication and interpersonal skills, Integrity and ethics and detail oriented.
Able to read relevant English methods and literature; Have the capability of English communication, communicate with external SME and suppliers.
Computer operation skill is well, such as practice in Excel, Word and PowerPoint. Be able to use PPT to prepare reports and use Excel and other laboratory quality control software to perform data analysis and graph it.
Be able to communicate and coordinate with multi departments and fulfill the task; arrange lab work to ensure the normal operation and coordinate or lead cross-function project.
Have the ability to work with mathematical concepts such as probability and statistical inference. Have the ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists, have the ability to explain various procedures or rules in the form of written, oral, charts or schedule form. Ability to be a subject matter expert for the related area.
6.生物制药或药品无菌灌装和相关的微生物技术、方法和法规要求的基础知识；在微生物限度 、无菌、抗微生物效果和防腐剂效果测试等各领域的知识；建立和维持环境监控、水系统取样 和测试计划的知识。环境监测方案知识应包括但不限于设计、应用和在生物技术， 生物制药及医药领域的管理；传统的微生物鉴定方法和快速微生物测试方法的知识。
Knowledge of fundamentals of bio-pharmaceutical or pharmaceutical aseptic filling and associated microbiological techniques, methods and regulatory requirements. Knowledge in the areas of Microbial Limits, Sterility, Anti- Microbial effectiveness and Preservative effectiveness testing; Knowledge in establishing and maintaining an EM, Water sampling and testing program. The knowledge of environmental monitoring program should include but not limited to design, applications and management in the biotechnology, bio-pharmaceutical or pharmaceutical fields. Knowledge of traditional microbial ID methods and strong support of rapid microbial methods.