GxP Quality Control Chemist

RXinsider LTD.; Houston, Northern (TX, KY); Hybrid; USD 65,000 - 90,000; Full time

Job summary

Eagle Analytical in Houston, TX is seeking a Quality Control Chemist to review and maintain analytical chemistry documentation, ensuring compliance with cGMP, cGLP, ISO 17025, USP and A2LA standards. You will collaborate with the lab to ensure data integrity and regulatory readiness across testing functions.

The role covers review of methods, validation documentation, test reports, quality investigations, and CAPA processes while supporting audits and continuous improvement initiatives.

Qualifications

• Requires a Bachelor's in Chemistry or Analytical Chemistry.
• Experience in regulated lab environments (ISO 17025, cGMP, cGLP) preferred.
• Strong understanding of analytical techniques (HPLC, GC-MS, UV-Vis).
• Experience reviewing GMP/GLP documentation and quality investigations.

Responsibilities

• Ensure compliance with SOPs and QMS.
• Interpret regulatory and accreditation standards (ISO 17025, cGMP, cGLP, USP, A2LA).
• Support regulatory inspections and client audits.
• Write, review, and approve SOPs, forms, and quality records.
• Review analytical test methods and related documentation for chemistry testing (UV-Vis, HPLC, HPLC-MS/MS, GC-MS).
• Review lab test reports, logs, validation protocols/reports.
• Ensure data integrity, accuracy, and traceability.
• Review and approve CAPAs, investigations, change controls, and customer complaints.
• Create audit finding reports and determine corrective actions.
• Support internal audits and routine walk-throughs.

Skills

Regulatory compliance

Data integrity

Analytical chemistry

Documentation review

Communication

Independent work with cross-functional

Education

Bachelor's degree in Chemistry

Tools

HPLC

HPLC-MS/MS

GC-MS

UV-Vis

LIMS / electronic document management

Job description

Eagle Analytical in Houston, TX is seeking a Quality Control Chemist to review and maintain analytical chemistry documentation, ensuring compliance with cGMP, cGLP, ISO 17025, USP and A2LA standards. You will collaborate with the lab to ensure data integrity and regulatory readiness across testing functions.

The role covers review of methods, validation documentation, test reports, quality investigations, and CAPA processes while supporting audits and continuous improvement initiatives.