Investigations Specialist

Integrated Resources, Inc ( IRI ); High Point (NC); On-site; USD 65,000 - 95,000; Full time

Job summary

Integrated Resources, Inc (IRI) is seeking a QC Investigation Writer to lead and document investigations in a GMP-regulated setting. The role focuses on root cause analysis, product impact evaluation, and CAPA development.

You will author OOS/OOT and deviations, review analytical data, ensure regulatory compliance, and collaborate with QC, QA, Microbiology, and Manufacturing teams to support audits and continuous improvement.

Qualifications

• Bachelor's degree in Chemistry, Biology, Microbiology, Biochemistry, Pharmaceutical Sciences, or related field.
• Minimum 2 years of GMP-regulated industry experience.
• Experience writing laboratory investigations (OOS/OOT, deviations, CAPAs).
• Strong technical writing, root cause analysis, and regulatory compliance knowledge.
• Experience with TrackWise or other electronic Quality Management Systems preferred.

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.

Skills

Technical writing

Root cause analysis

Regulatory compliance

Education

Bachelor's degree in Chemistry, Biology, Microbiology, Biochemistry, Pharmaceutical Sciences, or related field

Tools

TrackWise

Job description

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.