Sr Specialist II, Quality Control

Job Description

负责按照现行法规质量标准和操作规程开展原材料中间产品成品及稳定性样品的检验工作确保检测数据准确可靠支持产品放行及质量体系持续改进

1. 检测与分析

• 根据检验规程完成原辅料中间产品成品及稳定性样品检测
• 准确记录整理和审核实验原始数据确保结果真实完整可追溯
• 按规定及时出具检验结果并完成相关记录

2. 实验室管理

• 负责实验室仪器设备的日常使用点检维护和清洁
• 协助设备确认校准及验证活动
• 维持实验室5S管理要求及安全运行

3. 质量体系

• 严格遵守GMPCVP及数据完整性ALCOA要求
• 参与偏差OOS/OOTCAPA及变更管理等质量活动
• 参与方法验证方法确认及实验室持续改进项目
• 配合内部审计客户审计和监管检查工作

4. 团队协作

• 与生产质量保证QA技术转移等部门保持良好沟通
• 按要求完成培训并持续提升专业技能
• 完成部门经理交办的其他工作

教育背景

• 本科及以上学历
• 生物技术生物工程动物医学药学微生物学免疫学化学分析等相关专业

工作经验

• 5年以上制药生物制品疫苗等行业QC工作经验优先

专业能力

• 熟悉实验室基本操作和检测技术
• 具备细胞培养ELISA病毒滴度检测等经验者优先
• 熟悉GMP等法规要求者优先

Required Skills:

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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