Job DescriptionDescription:The NOI Investigations Specialist utilizes deductive reasoning, interviewing skills and technical knowledge when performing investigations to find causes of aberrant events and circumstances impacting the production, sale and/or maintenance of product shelf life of commercialized products. Judgment is relied upon for determination of product quality to be acceptable for release to market for customer use or rejection that may result in business impact of loss of revenue, missed ANDA submission timelines and customer dissatisfactions. They are responsible for assisting, working independently in the resolution of quality related issues by gathering relevant and factual information, determining the accurate cause and defining appropriate corrective/preventive actions to prevent recurrence. Additionally, they are expected to represent facts or theoretical hypotheses thoroughly and in a clear and concise manner that will withstand scrutiny during inspections by regulatory agencies, customers and vendors. They review the production, testing, handling, storage and handling of products & materials through investigation processes to assure products conform to established requirements and standards.
Essential Functions:- 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 supports 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.
- Writes 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 needed dons appropriate gowning and safety attire to maintain acceptable environmental conditions for maintaining product integrity and personal safety and
- Uses technical, scientific and professional judgment for assessing the effectiveness of CAPAs and communicates to supervisor and area management when deficiencies are found.
QualificationsEducation:- Bachelors Degree (BA/BS) Science or Engineering, Quality Mansgement or related field - Required
Experience:- 3 years or more in Working in the Pharmaceutical or Medical Device industry
- in Experience working in GMP/FDA regulated environment
- in Hands on experience in a production or laboratory working environment
Specialized Knowledge:- Use of Risk Assessment tools
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, with this position within the first 12 months. Amneal ranges reflect the Company's good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills.
At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life's many other commitments and opportunities.
