NOI Investigations Specialist
Amneal
Summary
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, this 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.
Job description
Essential Functions
- Perform investigations independently to assess aberrant events impacting product quality that could prevent product release.
- Perform interviews and schedule follow-up meetings in response to investigations.
- Perform gap assessments and root cause analysis evaluations to determine risk level utilizing root cause analysis tools such as FMEA, wishbone and/or 5 Why tools.
- 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 incident or event.
- 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 escalate the 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
- As required, adhere to gowning and safety protocols by wearing appropriate personal protective equipment (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.
Qualifications
- Bachelor's Degree (BA/BS) in Science or Engineering, Quality Management or related field - Required
- 3 years or more working in the Pharmaceutical or Medical Device industry
- 3 years of experience working in GMP/FDA regulated environment
- 3 years of hands-on experience in a production environment
- Use of Risk Assessment tools
Requirements
- Bachelor's Degree (BA/BS) in Science or Engineering, Quality Management or related field
- 3 years or more working in the Pharmaceutical or Medical Device industry
- 3 years of experience working in GMP/FDA regulated environment
- 3 years of hands-on experience in a production environment
- Use of Risk Assessment tools
Benefits
- Health Insurance
- Insurance Benefits
- 401(k) Matching
- Employee Well-Being Programs
Company overview
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) is a leading American publicly traded pharmaceutical company headquartered in Bridgewater, New Jersey. Founded in 2002 by brothers Chirag and Chintu Patel, the company has grown to become one of the largest and fastest-growing generic pharmaceutical manufacturers in the United States. Amneal operates as an integrated pharmaceutical company focused on developing, manufacturing, and distributing generic, brand, and biosimilar products. With approximately 8,100 employees globally, the company maintains operations across North America, Asia, and Europe. Amneal's business is organized into three main segments: a robust U.S. generics business with over 250 product families, a growing specialty pharmaceuticals division focused on central nervous system disorders and endocrine conditions, and an expanding biosimilars portfolio. The company has established itself as a leader in complex dosage forms and difficult-to-manufacture products, with manufacturing capabilities spanning oral solids, injectables, ophthalmics, liquids, topicals, transdermals, and respiratory devices. Amneal's mission 'We make healthy possible' reflects its commitment to providing affordable access to essential medicines while maintaining high-quality standards across its global operations.