Senior Analyst, Microbiology and Environmental Monitoring Lab (Biologics)

About the role

Roche is hiring a Senior Analyst for its microbiology and environmental monitoring laboratory in Shanghai, within the biologics business. The role covers routine microbiological testing of raw materials, packaging, bulk products and finished products, as well as environmental monitoring, process validation and cleaning validation, and supports engineering projects such as contamination control strategy and method validation.

Key responsibilities

• Perform microbiological testing on samples from incoming raw materials and packaging, bulk products and finished products, environmental monitoring, process validation and cleaning validation, and issue reliable analytical reports within a reasonable lead time.
• Follow all effective SOPs and safety requirements, and document laboratory work in line with cGMP.
• Assist the Head of the Microbiology lab with GMP self-inspections and related CAPAs to maintain global GMP compliance.
• Present technical analytical data clearly to internal investigations and regulatory inspectors.
• Maintain assigned instruments through calibration and upkeep, and report abnormal results and instrument issues promptly to supervisors.
• Keep the laboratory clean and maintain microbiology supplies inventory.
• Support lean initiatives in lab operations, test methods, documentation and equipment qualification.
• Support the Contamination Control Strategy (CCS) for the aseptic production line, environmental monitoring project execution, microbiology method transfer and cleaning/disinfection efficacy confirmation, and performance qualification of laboratory equipment.

Required profile

• Bachelor's degree or above; Life Sciences, Microbiology or Analytical Sciences preferred.
• 2+ years of QC experience focused on microbiology and aseptic processes; MNC biopharma experience preferred.
• Sound knowledge of quality control procedures and legal standards, with experience in aseptic assurance and microbiological testing.
• Experience in QC new facility startup readiness and ramp-up preferred.
• Fluent English communication skills; project management skills preferred.