GMP Analytical Data Review Scientist

BioSpace; Houston (TX); On-site; USD 85,000 - 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 objectives. This role blends data analytics, programming, and business intelligence with hands‑on laboratory testing, data management, and documentation.

You will review data and chromatographic reports for integrity and regulatory compliance, electronically sign off as author and reviewer, manage investigations, maintain

Qualifications

• Bachelor’s or Master’s degree in Chemistry, Analytical Chemistry, Biochemistry, or a related science field.
• Minimum 2 years’ experience in a regulated pharmaceutical analytical laboratory, or equivalent combination of education and experience.
• Proficiency with analytical instruments (HPLC, UPLC, GC, UV/Vis spectrophotometer), including operation, troubleshooting, and maintenance.
• Experience with LIMS (e.g., Empower, EagleTrax) and electronic data review.
• Strong knowledge of cGMP, cGLP, ISO 17025, USP, A2LA, and data integrity principles.
• Experience with laboratory documentation, technical review of analytical data, and OOS/OOT investigations.
• Excellent attention to detail, organizational, and communication skills; ability to work independently and collaboratively.
• Proficiency in Microsoft Office.
• Experience with method development, validation, and transfer; familiarity with regulatory submissions and quality systems.
• Exposure to multiple laboratory workstations, cross‑functional operations, and providing technical consultation is a plus.
• Knowledge of emerging analytical technologies and pharmaceutical testing applications.

Responsibilities

• Review analytical data, chromatographic reports, calculations, and laboratory worksheets for completeness, accuracy, and compliance with cGMP, cGLP, ISO 17025, USP, A2LA, and internal SOPs.
• Electronically sign off on data as both author and reviewer, following established procedures to ensure data integrity and regulatory compliance.
• Perform technical review and approval of Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations, ensuring results meet regulatory and quality standards prior to release.
• Maintain accurate and current documentation of laboratory activities, SOPs, and forms.
• Write, revise, and review SOPs and related forms in a timely manner as required.
• Support laboratory compliance audits, internal quality audits, and safety audits.
• Participate in investigations of deviations, errors, and discrepancies, and assist with CAPA plans and risk assessments.
• Communicate with laboratory staff to proactively address documentation quality and resolve deficiencies.
• Perform routine and non‑routine chemical analyses using HPLC, UPLC, GC, and spectrophotometry, as needed, under limited supervision.
• Process raw data using laboratory information management systems (e.g., EagleTrax, Empower) and ensure proper documentation and traceability.
• Perform routine testing on samples in a timely manner, tracking and meeting assigned deadlines.
• Notify supervisors promptly of unexpected test results and provide initial problem‑solving with minimal supervision.
• Perform maintenance, calibration, and troubleshooting of assigned laboratory equipment and systems; report calibration failures or repair needs promptly.
• Maintain familiarity with all applicable laboratory equipment, systems, and SOPs.
• Assist across workstations as needed, providing backup support for all laboratory functions.
• Maintain clean, orderly, and safe laboratory work areas while observing personal safety protocols.
• Process and analyze data to generate reports to support laboratory operations, quality review activities, and timely release of results to clients and internal stakeholders.
• Provide consultative support to customers regarding technical questions related to testing, methods, or analytical results.
• Participate in team discussions and contribute to achieving laboratory goals.
• Stay current with emerging technology, instruments, and regulatory changes, with emphasis on HPLC and pharmaceutical analytical chemistry applications.
• Assist in training new hires in entry‑level or laboratory support positions.
• Perform other duties and special projects assigned to support laboratory and quality operations.

Skills

Written Communication

Verbal Communication

Technical Writing

Deductive Reasoning

Analytical Instrumentation

Education

Bachelor’s or Master’s degree in Chemistry/Analytical Chemistry/Biochemistry

Masters or better in Biochemistry or related field

Masters or better in Chemistry or related field

Masters or better in Pharmacy or related field

Tools

HPLC

UPLC

GC

UV/Vis spectrophotometer

Empower (LIMS)

EagleTrax (LIMS)

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 objectives. This role blends data analytics, programming, and business intelligence with hands‑on laboratory testing, data management, and documentation.

You will review data and chromatographic reports for integrity and regulatory compliance, electronically sign off as author and reviewer, manage investigations, maintain