Analytical Investigations Lead - OOS, CAPA & Data

RXinsider LTD.; Houston (TX); On-site; USD 80,000 - 120,000; Full time

Job summary

Eagle Analytical seeks an Investigation Specialist with strong analytical chemistry expertise to lead investigations into deviations, OOS results, and quality events. You will conduct root cause analyses, interpret analytical data, and drive CAPAs for effective resolution.

Collaborate with QA, Production, R&D, and Regulatory Affairs to ensure timely, compliant reports and support audits. A detail-oriented, deadline-driven professional will thrive in this fast-paced environment.

Qualifications

• Bachelor’s degree in Chemistry or Analytical Chemistry (Master’s preferred).
• 3–5+ years in a regulated lab environment (pharma/biotech).
• Strong knowledge of analytical techniques (HPLC/GC/UV-Vis/FTIR).
• Experience with OOS, deviation investigations, and CAPA processes.
• Familiarity with GMP and regulatory requirements (FDA/ICH).
• Excellent problem-solving and documentation skills.

Responsibilities

• Lead, conduct, and document investigations into deviations, OOS/OOT, and quality events.
• Perform root cause analysis using analytical data and records.
• Interpret complex analytical data to identify trends and risks.
• Develop and track CAPAs for timely resolution.
• Prepare concise, compliant investigation reports per procedures and regulations.
• Collaborate with QA, Production, R&D, and Regulatory Affairs.
• Ensure investigations meet timelines and compliance standards.
• Support internal/external audits with documentation and SME input.
• Identify recurring issues and contribute to continuous improvement.
• Maintain current knowledge of regulatory guidelines and best practices.

Skills

Analytical chemistry

Root cause analysis

Data interpretation

Problem solving

Documentation

Critical thinking

Education

Bachelor's degree in Chemistry or Analytical Chemistry

Master's degree preferred

Tools

HPLC

GC

UV-Vis

FTIR

Job description

Eagle Analytical seeks an Investigation Specialist with strong analytical chemistry expertise to lead investigations into deviations, OOS results, and quality events. You will conduct root cause analyses, interpret analytical data, and drive CAPAs for effective resolution.

Collaborate with QA, Production, R&D, and Regulatory Affairs to ensure timely, compliant reports and support audits. A detail-oriented, deadline-driven professional will thrive in this fast-paced environment.