Qc Microbiology Analyst

Merck Merck · Pharma · Meath, Ireland

This role is for a QC Microbiology Analyst at Merck's biologics drug substance facility. The analyst will support routine laboratory operations, including testing, data processing, and microbiology studies, ensuring compliance with cGMP and cGLP standards. Responsibilities include performing various QC Microbiology tests, liaising with stakeholders, adhering to schedules, driving continuous improvement, and supporting audits.

What you'd actually do

  1. Operate as part of self-directed work team performing QC Microbiology testing and tasks to a high degree of precision and accuracy according to procedures.
  2. QC Microbiology testing includes but is not limited to bioburden, endotoxin, microbial identification, biological indicator, growth promotion, sterility check, pH, absence of contamination testing (BacT), environmental monitoring and validation studies.
  3. Liaise effectively with stakeholders such as QC Labs, Manufacturing, Tech Ops, CQV, Plant Engineering, IT and QA to ensure laboratory support is available as required and testing timelines are met.
  4. Ensure adherence to lab testing schedules, applying Lean Lab methodology.
  5. Ensure testing/data review and approval and that results are available within lead times to laboratory customers. Anticipated delays should be escalated, with proposed solutions for resolution.

Skills

Required

  • Automated Liquid Handling Systems
  • Chemical Testing
  • Compliance Analysis
  • Contamination Investigation
  • Corrective Action Management
  • Data Analysis
  • Environmental Monitoring
  • Environmental Monitoring Systems
  • Laboratory Information Management System (LIMS)
  • Laboratory Maintenance
  • Lean Management
  • Microbial Identification
  • Microbiological Analysis
  • Microbiological Cultures
  • Microbiology
  • Molecular Microbiology
  • Pharmaceutical Management
  • Quality Auditing
  • Quality Control Management
  • Quality Improvement
  • Quality Inspections
  • Quality Manuals
  • Quality Standards
  • Regulatory Compliance

What the JD emphasized

  • cGMP
  • cGLP