NOI Investigations Specialist

Job Overview Description: The NOI Investigations Specialist plays a critical role in ensuring product quality, compliance and patient safety by conducting comprehensive investigations into quality events that may impact the manufacturing, release, distribution, or shelf life of commercial products. Leveraging strong analytical, technical, and interviewing skills, the individual independently and collaboratively gathers and evaluates data, identifies root causes, assesses product impact and develops effective corrective and preventive actions (CAPAs) to prevent recurrence. The role requires sound judgment in determining product disposition, with decisions potentially affecting regulatory commitments, business performance, customer satisfaction and product availability. The specialist is responsible for clearly documenting and communicating investigative findings, supported by scientific rationale and factual evidence, in a manner that withstands scrutiny from regulatory agencies, customers and auditors. By reviewing manufacturing, testing, storage, handling and distribution activities to ensure compliance with established requirements and quality standards, the NOI Investigations Specialist serves as a key contributor to continuous improvement efforts and the organization’s commitment to delivering safe, effective and high-quality products. Essential Functions Perform investigations independently to assess aberrant events impacting product quality that could prevent product release; performs interviews and schedules follow-up meetings in response to investigations. Perform gap assessments and root cause analysis evaluations to determine risk level utilizing tools such as FMEA, wish‑bone and/or 5‑Why. Directly support the business through schedule/timeline adherence of NOI closures to allow for timely ANDA submissions, new product launches and batch releases. Recommend quality process improvements to increase efficiencies and performance of systems, operations and personnel and prevent reoccurrence of incidents or events. Write investigation reports in a clear and concise manner to withstand regulatory scrutiny, with sufficient detail to support decisions drawn and actions taken to resolve an event. Identify and resolve objectionable GMP issues which may impact product quality and escalatethe issues to supervisor in a timely manner. Ensure all work is performed and documented in accordance with existing Company policies and procedures, as well as GMP and health and safety requirements in the markets where product is sold. Additional Responsibilities Adhere to gowning and safety protocols by wearing appropriate PPE to maintain product quality, environmental compliance and personal safety. Apply technical expertise and professional judgment to determine CAPA effectiveness, ensuring deficiencies are identified, communicated and addressed through appropriate management channels. Education Bachelor’s Degree (BA/BS) in Science or Engineering, Quality Management or related field - Required Experience 3 years or more in the Pharmaceutical or Medical Device industry. 3 years of experience working in a GMP/FDA regulated environment. 3 years of hands‑on experience in a production setting. Specialized Knowledge Use of risk assessment tools. Compensation The base salary for this position ranges from $75,000 to $95,000 per year. The Company’s range reflects the good faith estimate of the base salary it believes it will pay for this position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to qualifications, geographic location and other relevant skills. Benefits Amneal offers a comprehensive, flexible and competitive benefits program for eligible positions that enables employees to choose the plans and coverage that meet their personal needs. A significant 401(k) matching contribution is also available to help employees save for retirement. Employee well‑being programs are available to support a healthy work‑life balance. #J-18808-Ljbffr Merck & Co.