Life in the Lab – Quality Assurance Microbiologist

Part of my Life in the Lab Series.

Here I summarise what each of my scientific roles have entailed.

As a Quality Assurance Microbiologist, what does the day entail?

08:30 hrs – Start shift

  • Develop and deliver training
  • Update documentation or delegate and meet with subject matter experts

10:30hrs – 15 minute break

  • Gather data for annual product reviews
  • Pursue special projects
  • Pursue signatures on validation reports from other departments
  • Contribute to IQ/OQ/PQ of LIMS system
  • Control Change Management for new LIMS system

12:30hrs – 45 minute lunch

  • Meeting with production managers, supervisor and filling room staff as part of out of specification results investigation
  • Oversee and control the of Sterile Media Fill Trial schedule
  • Write investigation reports
  • Conduct investigative monitoring or delegate
  • Map business  processes and improve processes

15:30hrs – 15 minute break

  • Perform housekeeping audit (weekly)
  • Consult pharmacopeia and Government regulations to ascertain state of compliance
  • Review pharmacopeia and Government regulations to ascertain impact of proposed changes and determine appropriate actions
  • Issue updated documentation and train staff if training required
  • Validate and commission new equipment including writing all validation documentation, creating or updating existing documentation and developing and delivering training to staff arising from this

17:00 – Depart for home

Roles Held

Microbiology TechnicianMicrobiology Analyst – Senior Microbiologist aka “Microbiology Officer” – Quality Assurance Microbiologist – Non Sterile Microbiology Team Leader