Pharma Data Integrity & Analytics Scientist

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

Job summary

Eagle Analytical seeks an Analytical Data Review Scientist to analyze, track, and report laboratory data supporting operations, quality, and compliance. The role combines data analytics, programming, and lab testing support to ensure timely, accurate sample testing and documentation.

The candidate will review data against cGMP/cGLP/ISO standards, utilize HPLC/UPLC/GC and LIMS (Empower, EagleTrax), and assist with audits, CAPAs, and regulatory submissions as needed.

Qualifications

• Requires a degree in chemistry or related science and relevant analytical laboratory experience.
• Experience with regulated pharma analytics and data review is essential.
• Proficiency with analytical instruments (HPLC, UPLC, GC, UV/Vis) and LIMS systems.
• Strong knowledge of cGMP, cGLP, ISO 17025, USP, A2LA, and data integrity.

Responsibilities

• Review analytical data, chromatographic reports, and worksheets for accuracy and regulatory compliance (cGMP/cGLP/ISO 17025).
• Electronically sign off data as author and reviewer, ensuring data integrity.
• Lead investigations of OOS/OOT ensuring regulatory standards before release.
• Maintain documentation of lab activities, SOPs, and forms; support audits.

Skills

Attention to detail

Organizational skills

Communication skills

Independence

Teamwork

Education

Bachelor's or Master’s degree in Chemistry/Analytical Chemistry/Biochemistry or related science

Tools

HPLC

UPLC

GC

UV/Vis spectrophotometer

LIMS (Empower, EagleTrax)

Job description

Eagle Analytical seeks an Analytical Data Review Scientist to analyze, track, and report laboratory data supporting operations, quality, and compliance. The role combines data analytics, programming, and lab testing support to ensure timely, accurate sample testing and documentation.

The candidate will review data against cGMP/cGLP/ISO standards, utilize HPLC/UPLC/GC and LIMS (Empower, EagleTrax), and assist with audits, CAPAs, and regulatory submissions as needed.