Senior Quality Investigation Specialist

Summary

Required Skills & Experience

→ 5+ years of pharmaceutical/biopharmaceutical GMP experience, ideally with significant deviation/nonconformance investigation responsibility\n → Hands-on experience with deviations, nonconformances, and GMP investigations\n → Demonstrated experience reviewing and/or approving investigations, not solely writing them\n → Strong knowledge of root-cause analysis and CAPA principles\n → Ability to critically evaluate investigation conclusions and identify unsupported assumptions, weak root-cause logic, or potential compliance risk\n → Strong GMP technical writing and document-review skills\n → Comfortable challenging, questioning, and coaching investigation owners and cross-functional SMEs\n → Experience working cross-functionally with areas such as Manufacturing/Operations, QA, QC, Engineering, or Maintenance\n → Ability to independently manage multiple investigations and drive them toward closure\n → Strong communication and stakeholder-management skills

Nice to Have Skills & Experience

→ API or small-molecule pharmaceutical manufacturing experience\n → Experience supporting investigations in a 24/7 manufacturing environment\n → QC/laboratory investigation experience, including testing failures or unexpected results\n → Experience with raw-material, bulk-solvent, supplier, or material-related investigations\n → Experience reviewing data-integrity or documentation-related events\n → Experience with microbial, environmental, or water-system investigations\n → COMET or similar electronic quality management system experience\n → Previous experience working in a senior QA, Quality Engineering, Manufacturing Quality, QC, or dedicated Investigations function\n → Local to Athens, GA or within reasonable commuting distance

Job Description

We are seeking an experienced Senior Quality Investigation Specialist to support a GMP pharmaceutical manufacturing site with the review, oversight, and approval of nonconformance and deviation investigations.\n\nThis is not primarily an investigation-writing position. Investigation owners will be responsible for drafting investigations. This individual will serve as the senior Quality reviewer responsible for assessing investigation quality, challenging root-cause conclusions, identifying potential compliance gaps, guiding investigation owners, and driving investigations toward timely and compliant closure.\n\nThe ideal candidate has significant experience within GMP pharmaceutical manufacturing and is comfortable independently reviewing complex investigations involving manufacturing processes, laboratory testing, materials, equipment, documentation, human performance, and other quality events.\n\nResponsibilities\n\n→ Review and approve GMP deviations and nonconformance investigations through closure\n → Evaluate investigations for technical accuracy, completeness, and regulatory/compliance risk\n → Challenge root-cause determinations and ensure conclusions are supported by objective evidence\n → Guide investigation owners through investigation milestones, requirements, and timelines\n → Review technical writing and identify weak or unsupported investigation language\n → Evaluate proposed corrective and preventive actions (CAPAs) for appropriateness and effectiveness\n → Conduct and/or support interviews with Manufacturing, Quality Control, Maintenance, Engineering, and other stakeholders\n → Coach investigation owners on root-cause analysis and investigation best practices\n → Identify recurring issues, investigation risks, and potential systemic quality concerns\n → Drive investigations toward compliant and timely closure in a fast-paced manufacturing environment

Job Description

Required Skills & Experience

→ 5+ years of pharmaceutical/biopharmaceutical GMP experience, ideally with significant deviation/nonconformance investigation responsibility\n → Hands-on experience with deviations, nonconformances, and GMP investigations\n → Demonstrated experience reviewing and/or approving investigations, not solely writing them\n → Strong knowledge of root-cause analysis and CAPA principles\n → Ability to critically evaluate investigation conclusions and identify unsupported assumptions, weak root-cause logic, or potential compliance risk\n → Strong GMP technical writing and document-review skills\n → Comfortable challenging, questioning, and coaching investigation owners and cross-functional SMEs\n → Experience working cross-functionally with areas such as Manufacturing/Operations, QA, QC, Engineering, or Maintenance\n → Ability to independently manage multiple investigations and drive them toward closure\n → Strong communication and stakeholder-management skills

Nice to Have Skills & Experience

→ API or small-molecule pharmaceutical manufacturing experience\n → Experience supporting investigations in a 24/7 manufacturing environment\n → QC/laboratory investigation experience, including testing failures or unexpected results\n → Experience with raw-material, bulk-solvent, supplier, or material-related investigations\n → Experience reviewing data-integrity or documentation-related events\n → Experience with microbial, environmental, or water-system investigations\n → COMET or similar electronic quality management system experience\n → Previous experience working in a senior QA, Quality Engineering, Manufacturing Quality, QC, or dedicated Investigations function\n → Local to Athens, GA or within reasonable commuting distance

Job Description

We are seeking an experienced Senior Quality Investigation Specialist to support a GMP pharmaceutical manufacturing site with the review, oversight, and approval of nonconformance and deviation investigations.\n\nThis is not primarily an investigation-writing position. Investigation owners will be responsible for drafting investigations. This individual will serve as the senior Quality reviewer responsible for assessing investigation quality, challenging root-cause conclusions, identifying potential compliance gaps, guiding investigation owners, and driving investigations toward timely and compliant closure.\n\nThe ideal candidate has significant experience within GMP pharmaceutical manufacturing and is comfortable independently reviewing complex investigations involving manufacturing processes, laboratory testing, materials, equipment, documentation, human performance, and other quality events.\n\nResponsibilities\n\n→ Review and approve GMP deviations and nonconformance investigations through closure\n → Evaluate investigations for technical accuracy, completeness, and regulatory/compliance risk\n → Challenge root-cause determinations and ensure conclusions are supported by objective evidence\n → Guide investigation owners through investigation milestones, requirements, and timelines\n → Review technical writing and identify weak or unsupported investigation language\n → Evaluate proposed corrective and preventive actions (CAPAs) for appropriateness and effectiveness\n → Conduct and/or support interviews with Manufacturing, Quality Control, Maintenance, Engineering, and other stakeholders\n → Coach investigation owners on root-cause analysis and investigation best practices\n → Identify recurring issues, investigation risks, and potential systemic quality concerns\n → Drive investigations toward compliant and timely closure in a fast-paced manufacturing environment