What are the responsibilities and job description for the Quality Control Microbiologist position at Radiant Systems?
Duration : 6 months
ACTUAL TITLE : QUALITY MANAGER
JOB RESPONSIBILITIES :
Author and review of GxP documents (e.g.- SOPs, Protocols, Technical Reports, Trend reports etc. related to QC microbiological and Environmental Monitoring activities)
Support site qualification / validation / commissioning activities as needed
Initiate and investigate deviations, and events in a Quality system, e.g. Trackwise
Initiate and author investigations related Out of Specification (OOS) or Out of Trend (OOT) results, deviations, as well as implementing corrective & preventive actions
Perform test results data entry, compilation, and archiving
Manage inventory and placing orders for materials
Additional duties as assigned
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS :
Bachelors degree in microbiology, or related field
4 years of experience in Quality Control or Microbiology / cGMP and increasing responsibility in biotech or related industry
Preferred requirements :
Masters degree in microbiology or a related field
Working knowledge of cell or gene therapy product testing and manufacturing
Experience in writing deviations / investigations in a quality system, e.g. Trackwise
Experience with environmental monitoring testing and product testing (sterility, mycoplasma, endotoxin)
Experience in writing & reviewing specifications, protocols, SOPs and Quarterly / AnnualEM trend reports
Knowledge and experience in Aseptic techniques, cleanroom behavior and Good Manufacturing Practice requirements
Experience in cleanroom gowning
General Microbiology knowledge and techniques
Experience with MODA laboratory system is a plus
Working knowledge of cell or gene therapy product testing, manufacturing, or development
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