Associate Manager, Quality Control

Job Description

岗位概述：

负责兽用疫苗产品在生产过程和放行前的质量检验与实验室管理，确保检验结果准确、合规并符合公司及监管机构的质量标准。作为QC团队的核心执行者，需协同生产、研发等部门，推动检验方法的优化与实验室持续改进。

主要职责：

• 协助QC经理建立和完善质量控制制度、检测流程，推动质量体系持续改进；
• 主导中国兽药典检测方法、兽药GMP等法规要求的落地执行；
• 监督并参与病毒含量、外源病毒、细胞库建立、菌毒种扩繁等工作；
• 协助QC经理审核检测记录、分析报告、分析方法验证、设备验证等放行文件；
• 分析检验趋势数据，提出质量改进建议，参与实验室流程优化与成本控制项目；
• 组织和跟进偏差、CAPA（纠正与预防措施）、变更控制，推动根本原因分析并实施改进措施；
• 配合GMP等监管检查与客户审计，准备审计资料并组织回复；
• 与研发、生产及公司其他工厂保持沟通，参与方法验证、方法转移、稳定性试验及质量问题解决。

任职要求：

• 学历专业：本科及以上学历，微生物学、生物制药、药学、兽医、生物技术等相关专业。
• 工作经验：5年以上动物生物疫苗行业QC工作经验，具备生物疫苗批检验、稳定性研究及方法学验证经验者优先。
• 专业能力：熟悉中国兽药典检测方法、兽药GMP等相关法规与标准；熟悉细胞培养、病毒培养等生物学方法及质控技术，能独立解决复杂的质量问题。
• 核心素养：具备较强的问题解决能力、数据分析能力和项目推进能力，能独立开展组织协调与跨部门沟通能力；数据敏感度高，逻辑严谨，责任心强，能承受一定工作压力；英语流利者优先。

Required Skills:

Adaptability, Analytical Instrumentation, Analytical Method Development, Decision Making, Detail-Oriented, Forensic Chemistry, Good Manufacturing Practices (GMP), Laboratory Information Management System (LIMS), Laboratory Operations, Quality Standards, Root Cause Analysis (RCA), Team Problem Solving, Technical Transfer, Technical Writing

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

Secondary Language(s) Job Description:

Position Summary:

Responsible for quality testing and laboratory management of veterinary vaccine products during production and prior to release, ensuring test results are accurate, compliant, and meet company and regulatory quality standards. As a core executor within the QC team, collaborate with Production, R&D and other departments to drive optimization of testing methods and continuous improvement of laboratory operations.

Key Responsibilities:

• Assist the QC Manager in developing and improving quality control policies and testing workflows, and drive continuous improvement of the quality system;
• Lead implementation of China Veterinary Pharmacopoeia testing methods and the requirements of Veterinary GMP and related regulations;
• Oversee and participate in work related to virus quantification, adventitious virus testing, cell bank establishment, and expansion of seed strains/viral stocks;
• Assist the QC Manager in reviewing test records, analytical reports, method validation studies, equipment qualification and other release documentation;
• Analyze testing trend data, propose quality improvement suggestions, and participate in laboratory workflow optimization and cost-control projects;
• Organize and follow up on deviations, CAPA (corrective and preventive actions) and change control; drive root cause analysis and implement corrective/improvement measures;
• Support GMP regulatory inspections and customer audits; prepare audit documentation and coordinate responses;
• Maintain communication with R&D, Production and other company plants; participate in method validation, method transfer, stability studies and quality issue resolution.

Qualifications:

• Education & Major: Bachelor’s degree or above in Microbiology, Biopharmaceuticals, Pharmacy, Veterinary Medicine, Biotechnology or related disciplines.
• Experience: Minimum 5 years of QC experience in the animal biological vaccine industry; candidates with experience in vaccine batch testing, stability studies and method validation are preferred.
• Technical Competencies: Familiar with China Veterinary Pharmacopoeia testing methods and Veterinary GMP regulations and standards; experienced in cell culture, virus culture and other biological methods and QC techniques; capable of independently resolving complex quality issues.
• Core Attributes: Strong problem-solving, data analysis and project management skills; able to independently organize, coordinate and communicate across departments; high data sensitivity, logical and detail-oriented, strong sense of responsibility and ability to work under pressure; fluency in English is a plus.

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:

Domestic

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

08/31/2026

*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.