Job Description
Specialist QA with experience in regulated industry and knowledge in: Environmental Monitoring, Microbial Identification (Micro ID), Critical Utilities (CU) monitoring Sampling monitoring: equipment and techniques Data trending and evaluation Microbiological testing methods and standards for clean rooms and controlled environments Aseptic behavior in manufacturing areas to prevent contamination Facility cleaning and disinfection Familiarity with the regulatory requirements and quality standards for environmental monitoring in the pharmaceutical industry: Annex 1, FDA Guidance, ISO-14644-1, USP Word processing, presentation, database, and spreadsheet application skills (Smartsheets, Microsoft Office: word, power point, and excel) Ability to use software tools and statistical techniques to visualize, interpret, and report on environmental/CU monitoring data Ability to analyze trend reports and environmental/CU data to identify areas for improvement Hands on experience in electronic syste...