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.