Analytical Chemistry Investigation Lead

RXinsider LTD.; Houston, Northern (TX, KY); Hybrid; USD 90,000 - 120,000; Full time

Job summary

Eagle is seeking an Investigation Specialist in Houston to lead and support investigations into laboratory deviations, OOS results, and quality events. You will perform root cause analyses, interpret complex analytical data, and develop CAPAs to ensure timely resolutions.

The role requires 3–5+ years in a regulated lab, with expertise in HPLC/GC/UV-Vis/FTIR and GMP familiarity. Strong communication and documentation skills are essential for audits and cross-functional collaboration.

Qualifications

• Bachelor’s degree in Chemistry, Analytical Chemistry, or a related scientific discipline (Master’s degree preferred).
• 3–5+ years of experience in a regulated laboratory environment (pharma/biotech or related industry).
• Strong knowledge of analytical techniques such as HPLC, GC, UV-Vis, FTIR, or similar instrumentation.
• Experience with OOS, deviation investigations, and CAPA processes.
• Familiarity with GMP and regulatory requirements (FDA/ICH).
• Excellent problem-solving, critical thinking, and analytical skills.
• Strong written and verbal communication skills.
• High attention to detail and organizational skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Experience in method validation, method transfer, or stability testing.
• Prior involvement in regulatory inspections or audits.
• Knowledge of statistical analysis tools and trending methodologies.
• Laboratory and office-based role with cross-department interaction.
• May require occasional extended hours to support critical investigations or deadlines.

Responsibilities

• Lead, conduct, and document investigations into laboratory deviations, non-conformances, OOS/OOT (Out-of-Trend) results, and quality events.
• Perform detailed root cause analysis using analytical data, laboratory records, and supporting documentation.
• Analyze and interpret complex analytical chemistry data to identify trends, anomalies, and potential risks.
• Develop, recommend, and track corrective and preventive actions (CAPAs) to ensure timely and effective resolution.
• Prepare clear, concise, and compliant investigation reports in accordance with internal procedures and regulatory requirements.
• Collaborate cross-functionally with Quality Assurance, Production, R&D, and Regulatory Affairs to support investigations and implement solutions.
• Ensure investigations are completed within established timelines and meet compliance standards.
• Support internal and external audits by providing documentation and subject matter expertise as needed.
• Identify recurring issues or trends and contribute to continuous improvement initiatives.
• Maintain a strong understanding of current regulatory guidelines and industry best practices related to analytical chemistry and quality systems.

Skills

Analytical skills

Problem solving

Written communication

Verbal communication

Attention to detail

Documentation

Education

Bachelor’s degree in Chemistry/Analytical Chemistry or related

Master’s degree preferred

Tools

HPLC

GC

UV-Vis

FTIR

Job description

Eagle is seeking an Investigation Specialist in Houston to lead and support investigations into laboratory deviations, OOS results, and quality events. You will perform root cause analyses, interpret complex analytical data, and develop CAPAs to ensure timely resolutions.

The role requires 3–5+ years in a regulated lab, with expertise in HPLC/GC/UV-Vis/FTIR and GMP familiarity. Strong communication and documentation skills are essential for audits and cross-functional collaboration.