NOI Investigations Specialist

Amneal•Piscataway, NJ

3d•$75,000 - $90,000

About The Position

The NOI Investigations Specialist conducts comprehensive investigations into quality events that may affect the manufacturing, release, distribution, or shelf life of commercial products. The role gathers and evaluates data, interviews relevant personnel, identifies root causes, assesses product impact and risk, and develops corrective and preventive actions (CAPAs) to prevent recurrence. The specialist applies sound judgment to product disposition decisions that may affect regulatory commitments, business performance, customer satisfaction, and product availability. The position documents and communicates investigative findings using scientific rationale and factual evidence, producing reports that can withstand scrutiny from regulatory agencies, customers, and auditors. It reviews manufacturing, testing, storage, handling, and distribution activities for compliance with established requirements and quality standards, and contributes to continuous improvement and the delivery of safe, effective, high-quality products.

Requirements

Bachelor’s degree (BA/BS) in Science, Engineering, Quality Management, or a related field.
At least 3 years of experience working in the pharmaceutical or medical device industry.
At least 3 years of experience working in a GMP/FDA-regulated environment.
At least 3 years of hands-on experience in a production environment.
Knowledge of risk assessment tools.

Responsibilities

Conduct independent investigations of aberrant events that may affect product quality or prevent product release.
Interview relevant personnel and schedule investigation follow-up meetings.
Perform gap assessments and root cause analysis to determine risk levels, using tools such as FMEA, wishbone, and 5 Why.
Adhere to investigation closure schedules and timelines to support timely ANDA submissions, new product launches, and batch releases.
Recommend quality process improvements that increase efficiency and performance and prevent recurrence of incidents or events.
Write clear, concise investigation reports with sufficient detail and support for conclusions and actions taken, suitable for regulatory scrutiny.
Identify and resolve objectionable GMP issues that may affect product quality, escalating issues to a supervisor in a timely manner.
Perform and document work in accordance with company policies and procedures, GMP, and applicable health and safety requirements.
Follow gowning and safety protocols and wear appropriate personal protective equipment (PPE) when required.
Apply technical expertise and professional judgment to assess CAPA effectiveness and ensure deficiencies are identified, communicated, and addressed through appropriate management channels.