Senior NOI Investigations Specialist

Role: Senior Specialist in NOI Investigations supporting pharmaceutical manufacturing quality assurance. Responsibilities: conduct independent investigations of aberrant events affecting product quality, perform root cause analyses using tools like FMEA and 5 Why, support timely closure of investigations to ensure regulatory submissions (e.g., ANDA), recommend process improvements, and prepare regulatory-compliant investigation reports. Required qualifications: Bachelor's in Science, Engineering, or Quality Management; 4+ years in GMP/FDA-regulated pharma or medical device environments, with hands-on experience in manufacturing or laboratory investigations and report writing. Preferred skills: experience with risk assessment tools. High-value specifics: focus on pharmaceutical product integrity, regulatory compliance, GMP adherence, and supporting batch releases and product launches. Collaboration: support cross-functional teams and escalate GMP issues as needed. Work setup: not specified, but implied to be in a regulated manufacturing environment.