职位描述
A Group Leader / Supervisor of Scientific Documentation is responsible for creating a smooth and efficient operation of the Analytical Sciences department with the investigation, review and approval of finished Laboratory Records and projects for the QA department. This will include all the projects’ review, for of Research & Development and Methods Development documents including, but not limited to protocols, reports, laboratory notebooks, general practices, batch cards, test requests, material specifications, certificates of analysis & compliance, and standard operation procedures; and to issue progress reports regarding the results and status of the chemists/scientists. The Scientific Documentation Supervisor will also lead and assist in the smooth and efficient operation of IRVINE’s quality system. Demonstrated ability to work in a team-oriented environment. Must have knowledge and experience in dealing with compliance issues. Additionally, the Scientific Documentation Supervisor will be required to write protocols, reports and other scientific documents. Ability to manage simultaneous tasks, work under pressure, track and monitor progress of multiple projects and follow through to goals. Ensure that project milestones are met and documented. This position requires the ability to manage and supervise employees and have good problem solving abilities. Must have chemistry experience. Previous supervisory experience highly desirable. Must have expertise in cGMP requirements for compendial criteria directly relating to analytical testing and analytical science (method development and validation). Must possess a command of cGMP requirements as it applies to pharmaceutical analytical data for test samples, demonstrate attention to detail, and possess an understanding of cGMP's relating to documentation requirements for the final release of analytical test data. Reviews data packets to ensure that all steps have been performed and verified where applicable, that all limits and specifications have been met. Ensures that data meets IRVINE, QA and Sponsor compliance standards. Ability to manage multiple projects and meet critical deadlines. Ability to manage successful interdisciplinary collaboration in a team setting using efficient problem solving skills. Must have strong scientific writing and reviewing experience. Demonstrated proficiency with the preparation of regulatory submissions, ability to manage multiple projects and meet critical deadlines. Benchmark improvements in chemistry productivity. Stability exp. is a plus. Demonstrated successful interdisciplinary collaboration in a team setting. Project management and group leader experience is a plus.Requires a M.S. with 5+ years of working experience of analytical method development, validation and method transfer experience (prefer Ph.D.). Knowledge of a variety of analytical laboratory instrumentation and equipment: HPLC, GC/MS, LC/MS etc. 工作职责：1.负责科学分析顺利有效的运行，为QA部门提供最终的实验报告。 2.负责协助IRVINE质量系统顺利有效的运行。 3.能够编写协议，报告和其他科学文件。 任职资格：M.S学位， 有5年以上的分析方法开发，验证和转移方法的相关工作经验（博士优先）。会各种分析实验室仪器及设备，例如高效液相色谱法，气相色谱/质谱，液相色谱/质谱等。职位概览 为配合公司实验室建设及开展检测业务，杭州艾品公司特此招聘以下各个部门的各类层次人员 (Technician, Associate, Supervisor, and/or Managers): Analytical Chemistry; Analytical Development; Stability; Biopharma; Microbiology; Quality Assurance; Business Development & Marketing; Finance; Human Resources; MIS; ICVS; Corporate Planning & Scheduling; Purchasing & Facilities;注意：成功应聘者将由杭州艾品公司直接聘用并提供薪酬及福利待遇。所有雇员与长三角绿色制药协同创新中心或其协同成立单位（包括浙江工业大学）将无任何形式的劳务关系。联系方式 Contact Info： 人事经理 hr@irvinepharma-china.com 请按照下列格式书写email主题：申请部门_职位_最高学历_姓名。举例，一位叫张三的申请者，最高学历是硕士（MS），申请分析部门(Analytical Chemistry) 的HPLC Supervisor职位，则主题格式为：Analytical Chemistry_HPLC Supervisor_MS_Zhang San。同时，请按照同样规则将所附简历命名。即其简历命名为Analytical Chemistry_HPLC Supervisor_MS_Zhang San.If using email to forward resume, please follow the renaming rules below: Department_Position_Highest degree achieved_Last name First name. For example, an applicant named Zhang San wants to apply for the position of HPLC Supervisor in the department of Analytical Chemistry. The highest degree he had is M.S. Then please write email subject as Analytical Chemistry_HPLC Supervisor_MS_Zhang San. On the other hand, please rename the resume to Analytical Chemistry_HPLC Supervisor_MS_Zhang San as well.
