Analytical Data Review Scientist - GMP/ISO Compliance

BioSpace; Houston (TX); On-site; USD 90,000 - 120,000; Full time

Job summary

Eagle Analytical is seeking an Analytical Data Review Scientist to analyze, track, and report laboratory and business data supporting operations, quality, and compliance. The role blends data analytics with hands-on lab support including HPLC/UPLC/GC and data management.

The candidate will ensure data integrity, participate in audits, and assist with SOP development and CAPA activities, driving regulatory compliance and timely result release.

Qualifications

• Bachelor's or Master's in a scientific field (Chemistry/Analytical Chemistry/ Biochemistry).
• Minimum 2 years in a regulated pharmaceutical analytical lab.
• Proficiency with HPLC/UPLC/GC/UV-Vis and LIMS.

Responsibilities

• Review data for completeness and compliance with cGMP/cGLP/ISO 17025/USP/A2LA SOPs.
• Electronically sign off data as author and reviewer.
• Investigate OOS and OOT findings per regulatory standards.
• Maintain thorough documentation of lab activities and SOPs.
• Support audits and CAPA/risk assessment processes.
• Process data and generate reports to support operations and timely release.
• Train new hires and provide technical consultation on testing results.

Skills

Written Communication

Wet Chemistry

Verbal Communication

Technical Writing

Deductive Reasoning

Analytical Instrumentation

Education

Masters in Biochemistry

Masters in Chemistry

Masters in Pharmacy

Tools

LIMS Empower

LIMS EagleTrax

Job description

Eagle Analytical is seeking an Analytical Data Review Scientist to analyze, track, and report laboratory and business data supporting operations, quality, and compliance. The role blends data analytics with hands-on lab support including HPLC/UPLC/GC and data management.

The candidate will ensure data integrity, participate in audits, and assist with SOP development and CAPA activities, driving regulatory compliance and timely result release.