天津招聘

职位描述：
Lab responsibilities
? Develops efficient and selective analytical procedures (with emphasis on HPLC and GC) for assigned projects
? Prepares qualification and validation protocols and reports for analytical procedures and instrumentation
? Performs sample analysis and reviews data packages
? Documents all analyses per SOPs
? Prepares high quality written documentations (notebooks, SOPs, and analytical procedures) and assists with regulatory documentation
? Troubleshoots analytical instrumentation
? Communicates effectively in verbal and written form on research results and plans
? Volunteers to assist with task not directly related to a specific project
? Demonstrates initiative in handling responsibilities
? Contributes to the technical growth of the department and company
? Attends project meetings and prepares project updates
? Participates in self-development activities
? Other duties as assigned
Quality/Regulatory responsibilities
? Demonstrates technical proficiency and self-assuredness in applying cGMP standards
? Applies cGMP concepts in association with department specific responsibilities
? Ensures all documentation produced is in compliance with cGMP standards
? Responsible for contributing to audit readiness and for participating in quality audits with FDA, other Regulatory Agencies, and customers, as needed
? Ensures work is in compliance with all state and federal regulations, including but not limited to GMP, DEA, FDA, etc 举报 分享

成立于2010年的庄信万丰（烟台）化工产品有限公司（原阿法埃莎星马（烟台）化工产品有限公司）是一个生产医药中间体和为生产原料药(API)提供从早期研发到商业化生产全面服务的CRO/CMO公司。庄信万丰（烟台）在2014年通过了ISO9001:2008质量审计认证；同年通过了庄信万丰原料药起始物供应商质量审计成为庄信万丰集团的常规原料药起始物(RSM)供应商。

凭借庄信万丰集团公司在医药服务、手性催化剂技术和原料药等全球业务产业链的优势，依托庄信万丰原料药业务的技术及质量管理体系以及先进的EH&S体系，中国大陆便捷原材料来源和丰富的人才储备，庄信万丰（烟台）能够为欧美、日韩等国家和地区以及中国国内的生物医药客户提供高性价比的个性化定制服务。我们杰出的研发团队能够提供FTE、API对照品及相关杂质的快速合成、路线探索、工艺技术开发及反应参数筛选等相关CRO服务。庄信万丰（烟台）的研发实验室、公斤级实验室及中试车间均按照国际EH&S管理标准装备建成，可实现从克级到百公斤级的全方位定制生产（CMO）服务。