職位描述
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. 工作職責：1.負責科學分析順利有效的運行，為QA部門提供最終的實驗報告。 2.負責協助IRVINE質量系統順利有效的運行。 3.能夠編寫協議，報告和其他科學文件。 任職資格：M.S學位， 有5年以上的分析方法開發，驗證和轉移方法的相關工作經驗（博士優先）。會各種分析實驗室儀器及設備，例如高效液相色譜法，氣相色譜/質譜，液相色譜/質譜等。職位概覽 為配合公司實驗室建設及開展檢測業務，杭州艾品公司特此招聘以下各個部門的各類層次人員 (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：成功應聘者將由杭州艾品公司直接聘用并提供薪酬及福利待遇。所有雇員與長三角綠色制藥協同創新中心或其協同成立單位（包括浙江工業大學）將無任何形式的勞務關系。聯系方式 Contact Info： 人事經理 hr@irvinepharma-china.com 請按照下列格式書寫email主題：申請部門_職位_最高學歷_姓名。舉例，一位叫張三的申請者，最高學歷是碩士（MS），申請分析部門(Analytical Chemistry) 的HPLC Supervisor職位，則主題格式為：Analytical Chemistry_HPLC Supervisor_MS_Zhang San。同時，請按照同樣規則將所附簡歷命名。即其簡歷命名為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.
