Deviation Investigations Specialist

Summary

1. Min 2 years Pharmaceutical industry experience in Deviation Investigations.2. Experience in Deviation Investigations, CAPAs, and FDA Audit exposure.3. This role will focus heavily on internal troubleshooting within Client and require frequent cross-functional collaboration. The individual should be confident in navigating conversations across teams, with strong negotiation skills and the ability to communicate effectively and proactively.POSITION SUMMARYThis position is responsible for leading and performing cGMP investigations supporting Oral Solid Dose (OSD) manufacturing, including complex manufacturing processes and equipment. The Investigator I authors and coordinates high-quality investigations for events occurring in Production, Engineering, Quality Control (QC) Laboratory, and related support areas, ensuring timely root cause identification, appropriate product impact assessments, and implementation of effective Corrective and Preventive Actions (CAPAs) to maintain compliant supply.The role applies scientific and technical judgment to evaluate manufacturing and laboratory data, interviews and observation, equipment/utilities performance, and process parameters to support robust root cause analysis and sustainable remediation for OSD unit operations (e.g., blending, granulation, compression, coating, encapsulation, etc.) and associated systems.POSITION REQUIREMENTSAny equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.Education/Certification/ExperienceMaster's or Ph.D. degree in a scientific or engineering discipline with relevant experience supporting investigations within pharmaceutical manufacturing, engineering, and/or QC laboratories; oral solid dosage (OSD) experience preferred.Experience using electronic quality systems and manufacturing/laboratory data systems (e.g., deviation/CAPA systems, MES, LIMS, historian/trending tools, AI tools) to support investigations, trending, and effectiveness monitoring preferred.Skills/Knowledge/AbilitiesOSD manufacturing and complex process/equipment knowledge sufficient to investigate events across Production, Engineering, and QC (e.g., blending, granulation, compression, coating, encapsulation, and supporting utilities).Strong Technical writing and documentation skills (deviations/nonconformances, OOS/OOT as applicable, product impact assessments, CAPA, and effectiveness checks) using Good Documentation Practices (GDP).Knowledge of cGMP, pharmaceutical quality systems, and data integrity expectations applicable to investigations, CAPA, and inspection readiness.Analytical and problem-solving capability using structured root cause analysis tools (e.g., 5-Why, fishbone, fault tree) to separate symptoms from true root causes.Ability to interpret and trend manufacturing/equipment/lab data using available systems and tools (e.g., eQMS, MES, LIMS, historian/trending tools, Excel/dashboards) to support risk-based decisions.Effective cross-functional facilitation and communication skills, including managing multiple investigations, aligning stakeholders, and clearly presenting complex technical information.Problem SolvingProactively works on problems of a moderate to complex Product where evaluation of contributing factors requires the analysis of situations or data and an in-depth knowledge and evaluation of various known and unknown factors.Seeks out all resources when selecting methods and techniques for obtaining results.Acts independently and proactively to recommend and administer methods and procedures for problem resolution.Able to identify solutions to general problems through collaboration and creativity.#J-18808-Ljbffr

Job Description

1. Min 2 years Pharmaceutical industry experience in Deviation Investigations.2. Experience in Deviation Investigations, CAPAs, and FDA Audit exposure.3. This role will focus heavily on internal troubleshooting within Client and require frequent cross-functional collaboration. The individual should be confident in navigating conversations across teams, with strong negotiation skills and the ability to communicate effectively and proactively.POSITION SUMMARYThis position is responsible for leading and performing cGMP investigations supporting Oral Solid Dose (OSD) manufacturing, including complex manufacturing processes and equipment. The Investigator I authors and coordinates high-quality investigations for events occurring in Production, Engineering, Quality Control (QC) Laboratory, and related support areas, ensuring timely root cause identification, appropriate product impact assessments, and implementation of effective Corrective and Preventive Actions (CAPAs) to maintain compliant supply.The role applies scientific and technical judgment to evaluate manufacturing and laboratory data, interviews and observation, equipment/utilities performance, and process parameters to support robust root cause analysis and sustainable remediation for OSD unit operations (e.g., blending, granulation, compression, coating, encapsulation, etc.) and associated systems.POSITION REQUIREMENTSAny equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.Education/Certification/ExperienceMaster's or Ph.D. degree in a scientific or engineering discipline with relevant experience supporting investigations within pharmaceutical manufacturing, engineering, and/or QC laboratories; oral solid dosage (OSD) experience preferred.Experience using electronic quality systems and manufacturing/laboratory data systems (e.g., deviation/CAPA systems, MES, LIMS, historian/trending tools, AI tools) to support investigations, trending, and effectiveness monitoring preferred.Skills/Knowledge/AbilitiesOSD manufacturing and complex process/equipment knowledge sufficient to investigate events across Production, Engineering, and QC (e.g., blending, granulation, compression, coating, encapsulation, and supporting utilities).Strong Technical writing and documentation skills (deviations/nonconformances, OOS/OOT as applicable, product impact assessments, CAPA, and effectiveness checks) using Good Documentation Practices (GDP).Knowledge of cGMP, pharmaceutical quality systems, and data integrity expectations applicable to investigations, CAPA, and inspection readiness.Analytical and problem-solving capability using structured root cause analysis tools (e.g., 5-Why, fishbone, fault tree) to separate symptoms from true root causes.Ability to interpret and trend manufacturing/equipment/lab data using available systems and tools (e.g., eQMS, MES, LIMS, historian/trending tools, Excel/dashboards) to support risk-based decisions.Effective cross-functional facilitation and communication skills, including managing multiple investigations, aligning stakeholders, and clearly presenting complex technical information.Problem SolvingProactively works on problems of a moderate to complex Product where evaluation of contributing factors requires the analysis of situations or data and an in-depth knowledge and evaluation of various known and unknown factors.Seeks out all resources when selecting methods and techniques for obtaining results.Acts independently and proactively to recommend and administer methods and procedures for problem resolution.Able to identify solutions to general problems through collaboration and creativity.#J-18808-Ljbffr