深圳招聘

Essential Functions基本功能
1.Responsible for keeping up-to-date and assuring compliance with Good Laboratory Practices, Good Manufacturing Practices, 21 CFR part 11 (where applicable), and any other local regulation applicable to the CNGB. Communicate with Associate Director of Quality Assurance on significant changes or concerns pertaining to compliance of GxP guidelines.
2.Responsible to ensure that CNGB is following established BioStorage operations procedures where applicable.
Responsible for assisting in the scheduling, facilitating and responding to all audits (client and regulatory) in addition to internal audits.
Responsible for all training activities at the CNGB which includes annual GxP training, maintaining training files, training curriculums, and auditing training records.
3.Ensure all service failures are identified, investigated, documented, and resolved appropriately. Responsible for tracking and follow-up on all CAPAs related to CNGB.
4.Responsible for the local oversight of the Document Management System in use at the CNGB. Activities include document routing, approval, and archival in addition to the administration of Qualtrax.
5.Review validation documents including, but not limited to, environmental chamber qualifications, and temperature/remote alarm monitoring systems
Assist with implementation of quality system in China branches of BioStorage Technologies.
6.Work with other functional areas and appropriate resources to develop and implement compliance and appropriate Quality control policies.
Propose recommendations and solutions that increase the likelihood of consistent operational success. Minor Responsibilities, Activities and Task Statements（附带（较小）职责，活动和任务陈述）:
Comply with established communications code concerning BioStorage Technologies business and patient confidential information.
Implement and monitor processes that ensure appropriate escalation of issues and continuous, appropriate communication of issues across the organization.
Participate on committees and public relations projects as requested.
Attend meetings as required such as I service meetings, committee meetings, department head meetings, etc.
Maintain department records.
Cooperate with BioStorage Technologies staff to achieve goals and maintain harmonious working relationships among employees.
Requisition supplies, equipment and forms needed in the department.
Perform other duties as directed by the Associate Director of Quality Assura
Required要求
Four-year degree in a science related field
Intermediate language skills (written and oral) in both English and Mandarin Chinese
Strong analytical skills and the ability to think creatively.
Excellent leadership skills and ability to work across organization.
Strong communication and interpersonal skills.
Experience in Good Laboratory Practices or Good Manufacturing Practices Facility.
Exposure to biological safety policies and guidelines.
Experience in the areas of Quality Improvement and Quality Assurance.
Demonstrated high level of initiative and ability to work independently.
Proven ability to work effectively with teams.
Competency with Microsoft Office products including Outlook, Word and PowerPoint.
Preferred优先（条件）
Experience writing and managing SOP’s and Quality Assurance and Business Policies.
Experience with FDA and/or customer audits in an FDA regulated environment. Working Conditions 工作条件
Employee will be working in a facility with potentially infectious materials. Employee will be responsible for maintaining a clean work environment and enforce and follow universal precautions for blood borne pathogens when working in an area considered to be potentially contaminated.
Some travel, including international travel may be required.
I have had the opportunity to review this job description. I also understand that it will be reviewed with me any time the responsibilities of this position are significantly changed. However, nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

公司网址： http://www.biostorage.com/http://www.biostorage.com/about-us/

注：该岗位的招聘单位为百秀瑞（北京）生物冷藏咨询公司，该公司是BioStorage Technologies 公司在中国的外资企业。请投递中英文版简历。

简历接收邮箱：pro-hr@genomics.org.cn
注：投递简历时，请注明应聘岗位。

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