QC Microbiologist

Position 1:

This role will be responsible for the review of GMP documentation respective to QC Microbiology assay and activities.  

Review will include:

• Environmental monitoring, water data including bioburden, endotoxin, TOC and conductivity

• In process testing including bioburden, endotoxin, viral testing

• Requirements for role will include understanding of related QCM assays and activities and experience reviewing GMP data and identifying aberrant data

• Experience with LIMS and electronic enterprise systems preferred. 

Position 2:

• This role will be responsible for the initiation and completion of lab related investigations respective to QC Microbiology assays and activities

• Investigation will include: Known lab errors investigation for root cause and impact

• Requirements for role will include understanding of related QCM assays and activities and experience in conducting investigations, root cause analysis and impact analysis

• Experience with Trackwise/LIMS preferred