Sr Specialist II, Quality Control

Job Description

岗位目的

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。

主要职责

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GMP、CVP及数据完整性（ALCOA+）要求。
• 参与偏差、OOS/OOT、CAPA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。

任职资格

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:

Adaptability, Analytical Instrumentation, Analytical Method Development, Communication, Continuous Improvement, Dissolution Testing, Driving Continuous Improvement, GMP Compliance, Karl Fischer Titrations, Laboratory Documentation, Laboratory Safety, Microbiological Analysis, Microbiological Test, Teamwork, Technical Writing, Troubleshooting, Use of Laboratory Equipment

Preferred Skills:

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Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

09/2/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.