Website Lenox Executive Search
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
Minimum Requirements:
Bachelor’s 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:
Master’s 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
Local travel between manufacturing sites required