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.
Education:
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
Skills:
Must be results-oriented, able to make decisions independently, and able to prioritize work per business needsStrong organizational and time management skills are necessaryAble to multitask and handle multiple priorities Strong verbal and technical writing skills requiredAbility to work flexible hours when needed to support investigation closures and lot releasesStrong knowledge of GMPs and FDA regulatory requirements - Advanced
