Lab Support & ASAT AM, Biologics QC

About the role

Roche is hiring a Lab Support & ASAT AM for a greenfield biologics facility in Shanghai. The role covers QC equipment and digital systems, drives lean laboratory management, sample and testing material management and other lab-supporting processes, and ensures physical and electronic setups meet standards and regulatory requirements. It also covers System Master Data maintenance and Routine Operation.

Key responsibilities

• Oversee qualification, CSV, calibration and maintenance of laboratory equipment and electronic systems, and direct daily QC support operations while managing and reviewing CAPAs.
• Govern sample and testing management systems such as account management and DI assessment.
• Lead investigations of deviations and unexpected results, escalate major issues, and ensure SOPs, documentation and tracking systems are compliant.
• Ensure audit readiness, support QC activities during regulatory inspections and audits, and provide technical support on lab topics.
• Set up master data and ensure data integrity, and support on-time delivery of QC digital systems such as LIMS.
• Lead QC system and electronic record development, including maintenance management systems and automation strategies (LIMS, Empower, SAP).
• Lead the QC Data Integrity governance program, including audit trail reviews, DI risk assessments and user access management, in line with ALCOA+ and cGMP.
• Drive continuous improvement, lean lab methods and digitalisation, including AI technology implementation, and lead a task force to introduce new technologies.

Required profile

• Bachelor's degree or above; Life Sciences, Pharmaceutical Sciences or Analytical Sciences preferred.
• 3+ years of QC experience; MNC biopharma preferred.
• Strong knowledge of QC procedures and legal standards, mathematics, data analysis and statistical methods.
• Experience in QC design, commissioning and qualification, routine operation and QC systems (e.g. LIMS, Empower).
• Experience in QC operational excellence (e.g. Lean and Six Sigma).
• Fluent English, written and spoken.

Required skills

• QC routine operation and QC systems (LIMS, Empower)
• Management of laboratory computerised/electronic systems (LIMS, SAP)
• Lean and Six Sigma
• Data integrity (ALCOA+) and cGMP
• Knowledge of aseptic processes preferred