QA Associate III

Novozen Healthcare LLC
NC, United States
Full-time

QA Associate III

  • 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.

22 hours ago
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