Kim Jackson Email & Phone Number

United States

Las Vegas, Nevada

Supervisor for clean room environmental monitoring and quality control personnel. Trend EM data and present in quarterly QRE. Create and revise cGMP SOPs, out of specification OOS reports, CAPA, document change requests. Follow USP <797> and other regulatory specifications. Perform validations and investigations. Maintain records and provide review and quality approval for manufacturing documents. Perform internal audits as well as external vendor audits for critical vendors and laboratories. Provide aseptic training for compounding pharmaceutical technicians. SME for EM department during FDA and state pharmacy board audits and responses. Interim Quality Assurance Manager.

Idaho Falls, Idaho

Set up laboratory and performed high complexity laboratory urine drug testing using Medica EasyRA. Entered results into patient charts.

Release and Stability testing to support pharmaceutical manufacturing under cGMP conditions. QC analysis using spectrometer and gel electrophoresis. Helped increase production volume by setting up QC media fill microbial procedures. Performed viable and non-viable environmental monitoring in ISO-5, 6,7 and 8 clean rooms and supporting areas. Wrote and reviewed validation, deviation and investigation reports.

Las Vegas, Nevada

Performed mold inspections and sampled surfaces and air for mold spore contamination. Wrote reports.

Corvallis, Oregon

Trace metals prep and analysis on ICP, AA. Microbial and wet chemistry analysis of drinking water, waste water, and sludge. Wrote SOPs, entered sample information into LIMS system.