# AM, Lab Support & ASAT, Biologics 生物制剂QC实验室支持与分析科学技术副经理 at Roche

Roche is hiring an AM, Lab Support & ASAT, Biologics 生物制剂QC实验室支持与分析科学技术副经理 in Shanghai, China. Level rates it Little AI ●○○○; you can [apply on Roche](https://jobsbylevel.com/go/273fb544-79d1-4e02-a8ed-2736e954e645?utm_medium=ai-agent).

AI Level 1, AI centrality 0 out of 100. Shanghai.

## Details

- Company: [Roche](https://jobsbylevel.com/companies/roche)
- AI level: AI Level 1 (score 0 out of 100)
- Location: Shanghai
- Posted: October 21, 2026
- Apply: https://jobsbylevel.com/go/273fb544-79d1-4e02-a8ed-2736e954e645?utm_medium=ai-agent

## Prepare for this job

The job page lists 5 likely interview questions for this offer, with a CV checklist: https://jobsbylevel.com/jobs/am-lab-support-asat-biologics-qc-at-roche-9a78c3

## Description

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position Roche is hiring for a greenfield facility in Shanghai and we are looking for Lab Support & ASAT AM, for who takes responsibility for QC equipment and digital systems, driving lean laboratory management, sample and testing material management,and other lab supporting processes. Also provides support during the project, ensuring both physical and electronic setups meet intended standards and regulatory requirements. Strong skill and experience are required to cover two areas: System Master Data maintenance and Routine Operation. ● The role supports on the equipment/system qualification and validation, sample/material management and QC Routine operation. ● Work independently and with a level of autonomy and authority in efficient execution to ensure on-going compliance against approved global/local procedure documents, current Good Manufacturing Practices, and CN/EU Annex-1 during the product lifecycle. ● Enable and self-motivate, and demonstrate leadership behavior and mindset Principle Roles & Responsibilities / Accountabilities主要职责/责任 Routine Operation: ● Oversee and manage the qualification, Computerized System Validation (CSV), calibration, and maintenance programs for relevant laboratory equipment and electronic systems, ensuring strict adherence to Roche’s QMS and regulatory guidelines. ● Direct daily QC support operations, as well as manage and review relevant CAPAs to maintain a global level of GMP compliance. Present technical & system procedure clearly and professionally to internal stakeholders and regulatory inspectors. ● Govern sample and testing management systems(eg account management, DI assessment), to ensure they are in good order to meet the analytical needs any time. ● Guide the team proactively identifying abnormal statuses, deviations, and unexpected results based on detailed data analysis. Lead critical investigations to resolve problems correctly and timely, and effectively escalate major issues to senior management. ● Ensure all necessary processes, documentation (SOPs), and tracking systems are in place and executed Complianced. ● Ensure audit readiness by complying with effective standards, regulatory/statutory, and cGMP requirements. Provide technical support on all lab-related topics during internal and external audits. ● Support all QC activities during regulatory inspections and audits and participate in the response to regulatory and global quality audits. System Management & Lean Lab: ● Set up master data according to business requirements and ensure data integrity. ● Digital system deployment: Support and ensure on time delivery for QC digital system(eg.LIMS). ● Lead QC system and electric record development according to the project plan and requirment in alignment with Roche standards.This involves creating a maintenance management system, and an automation strategy(eg. LIMS, Empower, SAP) and implementation to support robust operational readiness. ● Ensure the QC data flow generated by lab equipment/system and maintenance activities are compliance to DI requirements. ● Lead the QC Data Integrity (DI) Governance program: Establish and oversee robust DI control strategies, including routine audit trail reviews, DI risk assessments, and user access management. Ensuring all laboratory processes, electronic systems, and raw data generation strictly comply with ALCOA+ principles and global regulations. ● Ensure all data is maintained in accordance with cGMP and company standards for data integrity ● As the experienced SME, proactive

The description is cut here. Read the full offer: https://jobsbylevel.com/jobs/am-lab-support-asat-biologics-qc-at-roche-9a78c3

Source: https://jobsbylevel.com/jobs/am-lab-support-asat-biologics-qc-at-roche-9a78c3

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Level. https://jobsbylevel.com/jobs/am-lab-support-asat-biologics-qc-at-roche-9a78c3.

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