Role: QA Associate III

Location: North Cove, NC (onsite)

Duration: Longterm

Description:

• 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.