QA Associate III (6 resources) @ North Cove NC
- Microbial Investigation SME; Has working knowledge of TrackWise to manage investigation and CAPA documentation;
- Can determines scope product impact root cause corrective and/or preventive actions of microbial excursions including surfaces viable air nonviable air water bioburden and endotoxin testing results;
- Can identify potential root causes for excursions and immediate mitigation actions;
- Can assemble crossfunctional teams conduct interviews observe operations to complete investigations and lead process improvement CAPA projects to timely and effective closure;
- Can present and defend investigations during regulatory inspections as required;
- Must have great Technical Writing skills. Bachelor or Masters degree in science in Microbiology or related field with 2 years of experience in conducting root cause investigations in the pharmaceutical/medical products industry but with minimum 5 years of experience in Quality Operations Microbiology Laboratory and/or Quality.