NOI Investigations Specialist
Amneal Pharmaceuticals
August 21, 2026
Remote friendly (Brookhaven, NY)
United States
Operations
The NOI Investigations Specialist utilizes deductive reasoning, interviewing skills, and technical knowledge to investigate causes of aberrant events impacting the production, sale, and/or maintenance of product shelf life for commercialized products. They help resolve quality issues by gathering factual information, determining accurate root causes, and defining corrective/preventive actions to prevent recurrence. They document findings clearly to withstand scrutiny during regulatory, customer, and vendor inspections.
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 needs by meeting NOI closure timelines for timely ANDA submissions, product launches, and batch releases.
- Recommend quality process improvements to increase efficiencies and prevent recurrence.
- Write clear, concise investigation reports with sufficient detail for decisions and corrective actions.
- Identify and resolve objectionable GMP issues; escalate timely to supervisor.
- Ensure work is performed and documented per company policies/procedures and GMP/health & safety requirements.
Additional Responsibilities:
- Use appropriate gowning and safety attire as needed to maintain environmental conditions and personal safety.
- Assess CAPA effectiveness and communicate deficiencies to supervisor/area management.
Qualifications:
- Bachelor’s degree (BA/BS) in Science or Engineering, Quality Management, or related field (Required).
- 3+ years working in the pharmaceutical or medical device industry.
- Experience in GMP/FDA-regulated environments.
- Hands-on production or laboratory experience.
- Knowledge of risk assessment tools.
Compensation/Benefits (if included):
- Base salary range: $75,000–$90,000/year.
- Short-term incentive opportunity (bonus/performance-based award) within first 12 months.
Application instructions: None provided.
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 needs by meeting NOI closure timelines for timely ANDA submissions, product launches, and batch releases.
- Recommend quality process improvements to increase efficiencies and prevent recurrence.
- Write clear, concise investigation reports with sufficient detail for decisions and corrective actions.
- Identify and resolve objectionable GMP issues; escalate timely to supervisor.
- Ensure work is performed and documented per company policies/procedures and GMP/health & safety requirements.
Additional Responsibilities:
- Use appropriate gowning and safety attire as needed to maintain environmental conditions and personal safety.
- Assess CAPA effectiveness and communicate deficiencies to supervisor/area management.
Qualifications:
- Bachelor’s degree (BA/BS) in Science or Engineering, Quality Management, or related field (Required).
- 3+ years working in the pharmaceutical or medical device industry.
- Experience in GMP/FDA-regulated environments.
- Hands-on production or laboratory experience.
- Knowledge of risk assessment tools.
Compensation/Benefits (if included):
- Base salary range: $75,000–$90,000/year.
- Short-term incentive opportunity (bonus/performance-based award) within first 12 months.
Application instructions: None provided.