Life in the Lab – Microbiology Team Leader

Part of my Life in the Lab Series.

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

As a Microbiology Team Leader (non sterile laboratory), what does the day entail?

08:30 hrs – Start shift

  • Check how everyone is going today
  • Determine what needs to be done in next two months and delegate
  • Spot check equipment calibration labels
  • Conduct sampling of Purified Water system if short staffed
  • Followup with other departments regarding on going projects
  • Update documentation or delegate and meet with subject matter experts
  • Check and signoff on environmental monitoring data (worksheets) or delegate
  • Ensure any followup sampling has been completed, if not find out why and reschedule
  • Interview prospective staff

10:30hrs – 15 minute break

  • Check how everyone is going
  • Validation and introduction of equipment such as dust containment hoods and flammable liquid containers
  • After developing, deliver special training to production, eg Microbiology for non-microbiologists
  • Conduct antibiotic potency testing if short staffed (also method trouble shooting)
  • Read and record viable environmental monitoring results if short staffed
  • Train staff in sampling techniques or delegate
  • Pursue special projects or delegate
  • Sign off on environmental monitoring data
  • Delegate the testing of “urgent samples” and manage expectations of requestor
  • Meet with product representatives
  • Schedule and chair regional meeting of microbiologists as part of information sharing and method harmonisation
  • Conduct performance reviews of team

12:30hrs – 45 minute lunch

  • Check how everyone is going
  • Schedule or delegate external testing
  • Review the regulations for gaps and improvements
  • Formulate media if short staffed
  • Meeting with production managers, supervisor and filling room staff as part of out of specification results investigation
  • Write investigation reports
  • Deliver training to team (routine and special)
  • Conduct investigative monitoring or delegate
  • Investigate and report on environmental monitoring trends

15:30hrs – 15 minute break

  • Check how everyone is going
  • Attend site consolidation project meetings
  • Conduct internal audit (about every 6 months based on schedule)
  • Ensure OH&S is being followed (this is a constant thing every time I enter then lab)
  • Continue tasks from earlier in the day
  • Contribute to yearly budget
  • Catch up meeting with lab manager
  • Travel to other company sites in same city for meetings
  • Examine training status of team and schedule training / update records
  • Issue updated documentation and train staff if training required
  • Determine if tasks scheduled for tomorrow
  • Determine if there is anything that needs the later afternoon shift or night shift to be aware of

17:00 – Depart for home

Roles Held

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

Notes on the FDA’s Draft Data Integrity and Compliance With CGMP Guidance for Industry

Having worked in the pharmaceutical industry where I’ve dealt with electronic systems, paper based systems, programmed my own access databases and Excel spreadsheet  and been on projects such as LIMS system validation, I figured I’d make notes on the FDA’s 2016 guidance for industry document regarding Data Integrity and Compliance With CGMP.  This draft is for currently open for comment and the guidance addresses data integrity in:

  • drug manufacture
  • finished pharmaceuticals
  • positron emission tomography drugs

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FDA Guide To Inspections

A great reference for ensuring you are audit ready are the FDA’s Guide to Inspections documents and Guidance for Industry documents.

The FDA Inspection guides are freely available from here.

For my own reference and review, I’ve saved some of the Guidance for Industry documents below.  However, you can get them all from this link.