NOI Investigations Specialist

Role: NOI Investigations Specialist responsible for investigating quality events impacting product manufacturing, release, and compliance. Primary objectives include root cause analysis, risk assessment, and developing CAPAs to ensure product quality, regulatory adherence, and patient safety. Responsibilities encompass conducting independent investigations, performing gap assessments, supporting timely product releases and submissions, and documenting findings to withstand regulatory scrutiny. The role involves reviewing manufacturing and testing activities, identifying GMP issues, and recommending process improvements. Qualifications: Bachelor’s degree in Science, Engineering, or related field; minimum of 3 years’ experience in pharmaceutical or medical device industries within GMP/FDA-regulated environments; hands-on production experience. Specialized knowledge includes use of risk assessment tools like FMEA or 5 Why. High-value specifics: focus on GMP compliance, root cause analysis, and CAPA effectiveness; experience in pharma manufacturing or quality investigations; applicable to commercial products at various stages with regulatory considerations. Work setup and travel are not specified.