NOI Investigations Specialist

Summary

NOI Investigations SpecialistThe 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. The role requires sound judgment in determining product disposition, with decisions potentially affecting regulatory commitments, business performance, customer satisfaction, and product availability. The specialist is responsible for clearly documenting and communicating investigative findings, supported by scientific rationale and factual evidence, in a manner that withstands scrutiny from regulatory agencies, customers, and auditors. By reviewing manufacturing, testing, storage, handling, and distribution activities to ensure compliance with established requirements and quality standards, the NOI Investigations Specialist serves as a key contributor to continuous improvement efforts and the organization's commitment to delivering safe, effective, and high-quality products.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 required, adhere to gowning and safety protocols by wearing appropriate personal protective equipment (PPE) to maintain product quality, environmental compliance, and personal safety.Applies technical expertise and professional judgment to determine CAPA effectiveness, ensuring deficiencies are identified, communicated, and addressed through appropriate management channels.Education:Bachelors Degree (BA/BS) Science or Engineering, Quality Management or related field - RequiredExperience:3 years or more in Working in the Pharmaceutical or Medical Device industry3 years of Experience working in GMP/FDA regulated environment3 years on Hands on experience in a productionSpecialized Knowledge:Use of Risk Assessment toolsThe base salary for this position ranges from $75,000 to $95,000 per year.Required Skills:Change ControlData ReportingFacility InspectionGood Manufacturing PracticesISO 9000 SeriesQuality Management SystemsRegulatory ComplianceRisk ManagementRoot Cause AnalysisStatistical Process Controls

Job Description

NOI Investigations SpecialistThe 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. The role requires sound judgment in determining product disposition, with decisions potentially affecting regulatory commitments, business performance, customer satisfaction, and product availability. The specialist is responsible for clearly documenting and communicating investigative findings, supported by scientific rationale and factual evidence, in a manner that withstands scrutiny from regulatory agencies, customers, and auditors. By reviewing manufacturing, testing, storage, handling, and distribution activities to ensure compliance with established requirements and quality standards, the NOI Investigations Specialist serves as a key contributor to continuous improvement efforts and the organization's commitment to delivering safe, effective, and high-quality products.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 required, adhere to gowning and safety protocols by wearing appropriate personal protective equipment (PPE) to maintain product quality, environmental compliance, and personal safety.Applies technical expertise and professional judgment to determine CAPA effectiveness, ensuring deficiencies are identified, communicated, and addressed through appropriate management channels.Education:Bachelors Degree (BA/BS) Science or Engineering, Quality Management or related field - RequiredExperience:3 years or more in Working in the Pharmaceutical or Medical Device industry3 years of Experience working in GMP/FDA regulated environment3 years on Hands on experience in a productionSpecialized Knowledge:Use of Risk Assessment toolsThe base salary for this position ranges from $75,000 to $95,000 per year.Required Skills:Change ControlData ReportingFacility InspectionGood Manufacturing PracticesISO 9000 SeriesQuality Management SystemsRegulatory ComplianceRisk ManagementRoot Cause AnalysisStatistical Process Controls