NOI Investigations Specialist

Role: NOI Investigations Specialist responsible for conducting independent investigations into aberrant events affecting product quality in a GMP-regulated pharmaceutical environment. Objectives include identifying root causes, assessing risks, and implementing corrective/preventive actions to ensure product compliance and support timely product releases and regulatory submissions. Responsibilities: perform investigations, conduct gap assessments, utilize risk analysis tools (FMEA, 5 Why), write regulatory-ready reports, and recommend process improvements. Qualifications: Bachelor's degree in Science, Engineering, Quality Management, or related field; 3+ years’ experience in pharma or medical device industries within GMP/FDA regulated settings; hands-on experience in production or laboratory environments; proficiency in risk assessment tools. Preferred: experience in quality investigations, risk analysis, and regulatory compliance. High-Value specifics: focus on quality investigations impacting product release, with emphasis on GMP standards, regulatory compliance, and risk management. Work setup: not specified, but implied to be on-site or in a regulated environment requiring gowning and safety protocols.