QC Analyst III - Environmental Monitoring

Job description

The QC Microbiology Analyst will be responsible for performing functions including environmental monitoring, utilities monitoring, and testing in a facility that manufactures sterile products and tablets in a GMP environment. Major Responsibilities: Percentage of time spent on each responsibility Prepare such as change controls, risk assessments, SOP’s, protocols, final reports 20% Perform training of manufacturing and EM personnel 20% Perform environmental monitoring in aseptic, classified, and controlled areas (routine, batch, quarterly EM). Direct support of the manufacturing schedule will be required, which may include over time, weekend or shift work, and holidays 20% Perform utilities monitoring (WFI, CLST, PW, RO, CAIR, NIT, PWTR) and testing (Endotoxin, TOC, Conductivity, Nitrates, Bioburden) 20% Enumerate organisms for environmental monitoring and utility samples. 10% Perform basic lab tasks such as hood cleans, autoclave, dry heat oven, lab cleans etc. 10% Technical writing skills which require minimal guidance from management Ability to work hard and contribute to an enjoyable working environment Ability to work safely; seek out and encourage safe practices Gowning in an...