Lead QC Investigator: OOS/OOT & CAPA Expert

ClinLab Solutions Group; Massachusetts; On-site; USD 90,000 - 130,000; Full time

Job summary

ClinLab Solutions Group seeks a QC Investigator to lead and coordinate investigations of OOS, OOT, and other quality events within GMP-regulated QC. You will scrutinize data, methods, records and instrument outputs to ensure rigorous, timely, and compliant investigations.

The role requires a Bachelor's in a related science and 5+ years in QC/QA, with experience in cross-functional CAPA, regulatory inspections, and data integrity practices such as ALCOA+. Master’s preferred.

Qualifications

• Bachelor's degree in a related scientific discipline required; Master’s preferred.
• 5+ years in QC/analytical lab/QA or GMP-regulated environment.
• Leading OOS, OOT, deviation investigations experience.
• Experience in pharmaceutical/biotech/medical device regulated environments preferred.
• Strong analytical techniques, data interpretation, and LIMS/chromatography systems experience.
• Understanding GMP, quality systems, CAPA, deviations, change controls, and data integrity (ALCOA+).

Responsibilities

• Lead and coordinate investigations for OOS, OOT, atypical, and unexpected results.
• Review analytical data, records, test methods, instrument data, and supporting documentation.
• Apply scientific and risk-based approaches to determine root causes and impact.
• Develop hypotheses, ensure testing or data review, and author clear reports.
• Identify and elevate trends or recurring issues, supporting continuous improvement.
• Collaborate with cross-functional teams to support CAPA and effectiveness checks.
• Provide technical guidance to QC analysts and investigators, ensuring timelines.

Skills

Analytical data interpretation

Root-cause analysis

GMP compliance

CAPA

Regulatory knowledge

Cross-functional collaboration

Education

Bachelor's degree in Chemistry/Biochemistry/Pharmaceutical Sciences/Biology

Master’s degree preferred

Tools

LIMS

Chromatography data systems

Instrument data systems

Job description

ClinLab Solutions Group seeks a QC Investigator to lead and coordinate investigations of OOS, OOT, and other quality events within GMP-regulated QC. You will scrutinize data, methods, records and instrument outputs to ensure rigorous, timely, and compliant investigations.

The role requires a Bachelor's in a related science and 5+ years in QC/QA, with experience in cross-functional CAPA, regulatory inspections, and data integrity practices such as ALCOA+. Master’s preferred.