What are the responsibilities and job description for the QA Associate III (6 resources position at IT Minds LLC?
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, non-viable air, water, bioburden and endotoxin testing results;
- Can identify potential root causes for excursions and immediate mitigation actions;
- Can assemble cross-functional 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 Master’s 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.
