Senior NOI Investigations Specialist
Amneal Pharmaceuticals
August 21, 2026
Remote friendly (Brookhaven, NY)
United States
Corporate Functions
Job Description
The NOI Investigations Senior Specialist utilizes deductive reasoning, interviewing skills, and technical knowledge to investigate causes of aberrant events impacting the production, sale, and/or maintenance of commercial product shelf life. Determines product quality for release or rejection and defines appropriate corrective/preventive actions to prevent recurrence. Represents facts or hypotheses clearly for regulatory scrutiny and reviews production, testing, handling, and storage to ensure products meet established requirements.
Essential Functions:
- Perform investigations independently; conduct interviews and schedule follow-up meetings.
- Conduct gap assessments and root cause analyses to determine risk level using tools such as FMEA, fishbone, and/or 5 Whys.
- Support business timelines by adhering to NOI closure schedules for ANDA submissions, new product launches, and batch releases.
- Recommend quality process improvements to increase efficiency and prevent recurrence.
- Write clear, concise investigation reports with sufficient detail for decisions and actions.
- Assist NOI Investigations Specialists as needed.
- Identify and resolve objectionable GMP issues; escalate to supervisor in a timely manner.
- Ensure work is documented and performed in accordance with company policies and GMP/health & safety requirements.
Additional Responsibilities:
- Use appropriate gowning and safety attire as needed to maintain environmental conditions and personal safety.
- Assess effectiveness of CAPAs and communicate deficiencies to supervisor and area management.
Qualifications:
- Bachelor’s degree (BA/BS) in Science or Engineering, Quality Management, or related field (Required).
- 4+ years in pharmaceutical or medical device industry.
- Experience in GMP/FDA regulated environment.
- Hands-on production or laboratory experience.
- Experience conducting investigations and writing investigation reports.
- Knowledge of risk assessment tools.
Compensation & Benefits:
- Base salary: $85,000 to $100,000 per year; short-term incentive opportunity within first 12 months.
- Comprehensive benefits program with health/insurance and 401(k) matching (for eligible positions).
Application Instructions:
- Contact accommodations@amneal.com if you require a reasonable accommodation during the application process.
The NOI Investigations Senior Specialist utilizes deductive reasoning, interviewing skills, and technical knowledge to investigate causes of aberrant events impacting the production, sale, and/or maintenance of commercial product shelf life. Determines product quality for release or rejection and defines appropriate corrective/preventive actions to prevent recurrence. Represents facts or hypotheses clearly for regulatory scrutiny and reviews production, testing, handling, and storage to ensure products meet established requirements.
Essential Functions:
- Perform investigations independently; conduct interviews and schedule follow-up meetings.
- Conduct gap assessments and root cause analyses to determine risk level using tools such as FMEA, fishbone, and/or 5 Whys.
- Support business timelines by adhering to NOI closure schedules for ANDA submissions, new product launches, and batch releases.
- Recommend quality process improvements to increase efficiency and prevent recurrence.
- Write clear, concise investigation reports with sufficient detail for decisions and actions.
- Assist NOI Investigations Specialists as needed.
- Identify and resolve objectionable GMP issues; escalate to supervisor in a timely manner.
- Ensure work is documented and performed in accordance with company policies and GMP/health & safety requirements.
Additional Responsibilities:
- Use appropriate gowning and safety attire as needed to maintain environmental conditions and personal safety.
- Assess effectiveness of CAPAs and communicate deficiencies to supervisor and area management.
Qualifications:
- Bachelor’s degree (BA/BS) in Science or Engineering, Quality Management, or related field (Required).
- 4+ years in pharmaceutical or medical device industry.
- Experience in GMP/FDA regulated environment.
- Hands-on production or laboratory experience.
- Experience conducting investigations and writing investigation reports.
- Knowledge of risk assessment tools.
Compensation & Benefits:
- Base salary: $85,000 to $100,000 per year; short-term incentive opportunity within first 12 months.
- Comprehensive benefits program with health/insurance and 401(k) matching (for eligible positions).
Application Instructions:
- Contact accommodations@amneal.com if you require a reasonable accommodation during the application process.