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本科及以上学历，化工、材料、药学类及相关专业；Bachelor's degree or above, majoring in Chemical Engineering, Materials Science, Pharmacy or related fields.熟悉ISO9001质量管理体系要求；Familiar with ISO9001 quality management system requirements.熟悉GMP 要求或ISO13485质量管理体系或药包材要求； Familiar with GMP requirement or ISO13485 system or drug packaging materials requirement.资质CERTIFICATIONS:
CET -4
经验EXPERIENCE:
具备1年及以上质量体系管理的工作经验。At least 1 year work experience in QMS.胜任工作要求THOSE NECESSARY TO PERFORM THE JOB COMPETENTLY:
有一次性耗材的质量管理经验优先；Experience in quality management of single-use product is preferred.有医疗器械、药包材、药品相关的质量体系管理经验者优先。Experience in QMS related to medical devices, pharmaceutical packaging materials, and drugs is preferred.有内审员资格证者优先。Internal auditor is preferred.必要资质PREFERRED QUALIFICATIONS:
精通Office办公套件（Excel、PPT、Word）；Proficient in Office suite (Excel, PPT, Word).具有质量管理体系工作经验；Have experience in quality management system.扎实的书面和口头沟通技巧；Solid written and verbal communication skills.具备一定的分析数据的能力；Have certain data analyze ability.良好的英语读写能力，通过CET-4及以上；Good English reading and writing skills, passed CET-4 or above.有良好的沟通能力和团队协作能力，有较强的责任心；Has good communication and teamwork skills, and a strong sense of responsibility.工作描述HOW YOU WILL THRIVE AND CREATE AN IMPACT:
维护并改进质量管理体系，负责质量管理体系文件、质量记录管理，整理归纳文件及相关记录；Assist the manager of quality department to establish the document management system, and implement the management of the formulation, review, revision, distribution, recovery, storage and destruction of documents.管理质量体系文件和记录，并对文件和记录的制订、审核、修订、印发、收回、保管、销毁工作实施管理；管理ETQ中质量体系文件及记录的流程；Manage quality system documents and records, and implement management of the formulation, review, revision, issuance, retrieval, storage, and destruction of documents and records; The process of managing quality system documents and records in ETQ.负责物料和产品的放行，负责物料、中间品、半成品和成品的检验记录审核，确保原辅料、包装材料、中间产品、待包装产品和成品符合要求和质量标准，并完成ERP系统操作；Responsible for the release of materials and products, reviewing inspection records of materials, intermediate products, semi-finished products, and finished products, ensuring that raw materials, packaging materials, intermediate products, products to be packaged, and finished products meet requirements and quality standards, and completing ERP system operations.负责质量月报和年报的编制；Responsible for preparing monthly and annual quality reports.负责公司计量器具的档案及送检校准管理工作；Responsible for the management of archives and calibration of measuring instruments.负责整理并跟踪偏差、变更、CAPA、不合格品处置的完成情况和结果；Responsible for organizing and tracking deviations, changes CAPA、 The completion status and results of the disposal of non-conforming products.协助监督公司现场的质量管理，对公司现场进行监督检查； Assist in supervising the on-site quality management of the company and conducting supervision and inspection of the company's site.完成领导安排的其他工作。Complete other tasks assigned by the leader.Disclaimer:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer.
Why Avantor?
Dare to go further in your career. Join our global team of 14,000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science.
The work we do changes people's lives for the better. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his mom's voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at Avantor.
We are committed to helping you on this journey through our diverse, equitable and inclusive culture which includes learning experiences to support your career growth and success. At Avantor, dare to go further and see how the impact of your contributions set science in motion to create a better world. Apply today!
EEO Statement:
We are an Equal Employment/Affirmative Action employer and VEVRAA Federal Contractor. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.
If you need a reasonable accommodation for any part of the employment process, please contact us by email at recruiting@avantorsciences.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
3rd party non-solicitation policy:
By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation