NOI Investigations Specialist

About the role

The NOI Investigations Specialist utilizes deductive reasoning, interviewing skills, and technical knowledge to perform investigations into aberrant events and circumstances impacting the production, sale, and/or maintenance of product shelf life for commercialized products. This role relies on judgment to determine product quality acceptability for market release or rejection, which may result in business impacts such as loss of revenue, missed ANDA submission timelines, and customer dissatisfaction.

Responsibilities

• Perform investigations independently to assess aberrant events impacting product quality that could prevent product release.
• Conduct interviews and schedule follow-up meetings in response to investigations.
• Perform gap assessments and root cause analysis evaluations to determine risk levels using tools such as FMEA, fishbone diagrams, and/or 5 Whys.
• Support the business through adherence to NOI closure timelines to enable timely ANDA submissions, new product launches, and batch releases.
• Recommend quality process improvements to increase efficiencies, enhance system performance, and prevent recurrence of incidents.
• Write investigation reports clearly and concisely to withstand regulatory scrutiny, with sufficient detail to support decisions and actions taken.
• Identify and resolve objectionable GMP issues that may impact product quality and escalate issues to supervisors in a timely manner.
• Ensure all work is performed and documented in accordance with company policies, GMP, and health and safety requirements.
• Don appropriate gowning and safety attire to maintain environmental conditions for product integrity and personal safety.
• Use technical, scientific, and professional judgment to assess the effectiveness of CAPAs and communicate deficiencies to supervisors and management.

Requirements

• Bachelor’s Degree (BA/BS) in Science, Engineering, Quality Management, or a related field (required).
• 3+ years of experience working in the pharmaceutical or medical device industry.
• Experience working in a GMP/FDA-regulated environment.
• Hands-on experience in a production or laboratory working environment.
• Knowledge of risk assessment tools.

Pay

The base salary for this position ranges from $75,000 to $90,000 per year. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, within the first 12 months.

Benefits

Amneal provides a comprehensive, flexible, and competitive benefits program, including:

• Above-market, diverse, and robust health and insurance benefits tailored to meet varied employee needs.
• A significant 401(k) matching contribution to support retirement savings.
• Programs promoting employee well-being, helping balance career and personal commitments.