Responsible for writing investigations generated within the QC Microbiology testing group.
Responsible for performing thorough, detailed and timely investigations and generation of high quality and timely investigation reports. Investigation areas will include testing deviations, invalid or questionable result investigations, instrument calibration Out-of-Tolerance reports, and environmental monitoring excursions.
Responsible for review of microbiological laboratory data generated in support of commercial and clinical manufacturing.
Responsible for reviewing cGMP testing data generated by the QC Microbiology testing group for completeness and accuracy.
Lead continuous improvement projects.
Revise standard operating procedures.
Represent the QC Microbiology group when working with cross-functional teams.
Assist with instrument validations and other special projects.
BS in Microbiology or related field with 2-4 years of industry experience, preferably in the biopharmaceutical industry is required.
Ability to interpret and document test results according to standard operating procedures using all standard Quality systems
Must be proficient with Microsoft Office Suite.
Must have excellent verbal and written communication skills.
Experience with cGMP’s, SOP’s, Labware LIMS and TrackWise is preferred.