Senior Quality / Deviation Investigation Specialist

Summary

Location: North CarolinaType: ContractDuration: Short-Term ProjectIndustry: Pharmaceutical / Biopharmaceutical ManufacturingPosition SummaryWe are looking for an experienced Quality professional to provide support for GMP investigations and quality event management within a pharmaceutical manufacturing environment. The role will focus on evaluating deviations, determining root causes, assessing potential impact, supporting CAPA activities, and ensuring quality investigations are completed accurately and on schedule.ResponsibilitiesManage and support investigations involving manufacturing deviations, process-related events, equipment, utilities, and quality systems.Evaluate event information, batch documentation, manufacturing records, and technical data to identify contributing factors and determine product or process impact.Conduct structured root cause analysis using appropriate investigation methods and tools.Collaborate with Quality, Manufacturing, Engineering, Validation, Maintenance, and other cross-functional teams to collect information and resolve investigation actions.Prepare complete investigation reports documenting the issue, impact assessment, investigation findings, root cause, and corrective actions.Assist with CAPA development, effectiveness assessments, and follow-up activities related to investigation findings.Examine batch records, equipment logs, maintenance records, and other GMP documentation as needed.Monitor investigation timelines, action items, and approvals to support timely closure of quality events.Ensure all investigation records meet cGMP, GDP, data integrity, and internal quality system requirements.Qualifications8+ years of experience in Quality Assurance, deviation investigation, manufacturing quality, or a related pharmaceutical environment; 10+ years preferred.Demonstrated hands-on experience conducting deviation investigations in a GMP manufacturing setting.Experience in sterile, biologics, pharmaceutical, or other highly regulated manufacturing environments strongly preferred.Working knowledge of root cause analysis, CAPA, quality risk assessment, and investigation documentation.Strong technical writing, communication, and cross-functional teamwork skills.Ability to work independently, handle multiple investigations, and meet established project deadlines.#J-18808-Ljbffr

Job Description

Location: North CarolinaType: ContractDuration: Short-Term ProjectIndustry: Pharmaceutical / Biopharmaceutical ManufacturingPosition SummaryWe are looking for an experienced Quality professional to provide support for GMP investigations and quality event management within a pharmaceutical manufacturing environment. The role will focus on evaluating deviations, determining root causes, assessing potential impact, supporting CAPA activities, and ensuring quality investigations are completed accurately and on schedule.ResponsibilitiesManage and support investigations involving manufacturing deviations, process-related events, equipment, utilities, and quality systems.Evaluate event information, batch documentation, manufacturing records, and technical data to identify contributing factors and determine product or process impact.Conduct structured root cause analysis using appropriate investigation methods and tools.Collaborate with Quality, Manufacturing, Engineering, Validation, Maintenance, and other cross-functional teams to collect information and resolve investigation actions.Prepare complete investigation reports documenting the issue, impact assessment, investigation findings, root cause, and corrective actions.Assist with CAPA development, effectiveness assessments, and follow-up activities related to investigation findings.Examine batch records, equipment logs, maintenance records, and other GMP documentation as needed.Monitor investigation timelines, action items, and approvals to support timely closure of quality events.Ensure all investigation records meet cGMP, GDP, data integrity, and internal quality system requirements.Qualifications8+ years of experience in Quality Assurance, deviation investigation, manufacturing quality, or a related pharmaceutical environment; 10+ years preferred.Demonstrated hands-on experience conducting deviation investigations in a GMP manufacturing setting.Experience in sterile, biologics, pharmaceutical, or other highly regulated manufacturing environments strongly preferred.Working knowledge of root cause analysis, CAPA, quality risk assessment, and investigation documentation.Strong technical writing, communication, and cross-functional teamwork skills.Ability to work independently, handle multiple investigations, and meet established project deadlines.#J-18808-Ljbffr