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Company

Original Job Post

Amneal Pharmaceuticals · 2 days ago

NOI Investigations Specialist

Piscataway, NJ

Full-time

Onsite

Mid Level

3+ years exp

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Responsibilities

Perform investigations independently to assess aberrant events impacting product quality that could prevent product release. Performs 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 the product is sold.

Qualification

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Pharmaceutical industry experienceMedical device industry experienceGMP/FDA regulationsProduction experienceLaboratory experienceRisk assessment toolsResults-orientedAble to prioritize work organizational skillsTime managementMultitasking verbal communicationTechnical writingFlexible knowledge

Required

Bachelors Degree (BA/BS) Science or Engineering, Quality Management or related field

3 years or more in Working in the Pharmaceutical or Medical Device industry

Experience working in GMP/FDA regulated environment

Hands on experience in a production or laboratory working environment

Must be results-oriented, able to make decisions independently, and able to prioritize work per business needs

Strong organizational and time management skills are necessary

Able to multitask and handle multiple priorities

Strong verbal and technical writing skills required

Ability to work flexible hours when needed to support investigation closures and lot releases

Strong knowledge of GMPs and FDA regulatory requirements - Advanced

Use of Risk Assessment tools

Company

Amneal Pharmaceuticals

Glassdoor

3.5

Amneal Pharmaceuticals manufactures, markets and/or distributes more than 88 drugs in the United States.

Founded in 1995

Bridgewater, New Jersey, USA

5,001-10,000 employees

http://amneal.com/

H1B Sponsorship

Amneal Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2023 (24)

2022 (37)

2021 (44)

2020 (33)