Investigations Specialist

Summary

Job Summary:The QC Investigation Writer leads and documents laboratory investigations in a GMP-regulated pharmaceutical, biotechnology, or biologics environment. The role focuses on identifying root causes, assessing product impact, ensuring regulatory compliance, and developing effective CAPAs.Key Responsibilities:Author and lead OOS, OOT, Environmental Monitoring (EM), and laboratory deviation investigations.Review analytical and microbiological data to determine root causes and product impact.Prepare investigation reports, CAPAs, deviations, and change controls.Ensure compliance with FDA regulations, cGMP requirements, and data integrity standards.Collaborate with QC, QA, Microbiology, and Manufacturing teams.Support audits, regulatory inspections, and continuous improvement initiatives.Qualifications:Bachelor's degree in Chemistry, Biology, Microbiology, Biochemistry, Pharmaceutical Sciences, or a related field.Minimum 2 years of GMP-regulated industry experience.Experience writing laboratory investigations, including OOS/OOT, deviations, and CAPAs.Strong technical writing, root cause analysis, and regulatory compliance knowledge.Experience with TrackWise or other electronic Quality Management Systems preferred.

Job Description

Job Summary:The QC Investigation Writer leads and documents laboratory investigations in a GMP-regulated pharmaceutical, biotechnology, or biologics environment. The role focuses on identifying root causes, assessing product impact, ensuring regulatory compliance, and developing effective CAPAs.Key Responsibilities:Author and lead OOS, OOT, Environmental Monitoring (EM), and laboratory deviation investigations.Review analytical and microbiological data to determine root causes and product impact.Prepare investigation reports, CAPAs, deviations, and change controls.Ensure compliance with FDA regulations, cGMP requirements, and data integrity standards.Collaborate with QC, QA, Microbiology, and Manufacturing teams.Support audits, regulatory inspections, and continuous improvement initiatives.Qualifications:Bachelor's degree in Chemistry, Biology, Microbiology, Biochemistry, Pharmaceutical Sciences, or a related field.Minimum 2 years of GMP-regulated industry experience.Experience writing laboratory investigations, including OOS/OOT, deviations, and CAPAs.Strong technical writing, root cause analysis, and regulatory compliance knowledge.Experience with TrackWise or other electronic Quality Management Systems preferred.