Quality Compliance Chemist – ISO 17025 & cGMP Focus

Eagle Analytical; Phenix City (AL); On-site; USD 65,000 - 90,000; Full time

Job summary

Eagle Analytical seeks a Quality Control Chemist to review and maintain analytical chemistry documentation ensuring regulatory compliance and data integrity. You will collaborate with lab operations to support audits, investigations, and continuous improvement across chemistry testing.

The role emphasizes SOP development, method validation review, and documentation quality across UV-Vis, HPLC, and GC-MS platforms. A strong eye for detail is essential.

Qualifications

• Bachelor’s degree in Chemistry, Analytical Chemistry, or a related scientific discipline required.
• Experience in a regulated laboratory environment (ISO 17025, cGMP, cGLP) preferred.
• Experience supporting analytical chemistry testing laboratories is strongly preferred.
• Strong understanding of analytical chemistry techniques and instrumentation (HPLC, HPLC-MS/MS, GC-MS, UV-Vis).
• Working knowledge of method validation, data review, and laboratory quality systems.
• Experience reviewing GMP/GLP documentation and quality investigations.
• Excellent written and verbal communication skills.

Responsibilities

• Ensure compliance with Eagle Analytical policies, SOPs and the Quality Management System.
• Interpret and apply ISO 17025, cGMP, cGLP, USP and A2LA requirements.
• Support regulatory inspections, client audits, and accreditation assessments as required.
• Write, review, and approve SOPs, work instructions, forms, and quality records.
• Review and approve analytical test methods and related documentation for chemistry testing (HPLC, GC-MS, UV-Vis).
• Review laboratory test reports, chemistry logs, worksheets, validation protocols and validation reports.
• Ensure analytical data integrity, accuracy, completeness, and traceability.
• Review and approve quality investigations (OOS, NCR, deviations, CAPA, change controls, customer complaints).
• Evaluate root cause analyses and corrective action plans.
• Create audit finding reports and determine corrective actions.
• Support internal audits of quality systems and documentation.
• Perform walk-through audits to ensure compliance across departments.
• Manage auditing, storage, and retention of quality documents and quarantined materials.
• Prepare and maintain quality training materials.
• Support continuous improvement initiatives for quality systems and documentation.
• Assist in creating and maintaining quality manuals and controlled documents.
• Perform additional duties and special projects to support quality and regulatory objectives.

Skills

Regulatory compliance

Documentation review

SOP writing

Cross-functional collaboration

Education

Bachelor’s degree in Chemistry/Analytical Chemistry

Tools

HPLC

HPLC-MS/MS

GC-MS

UV-Vis

Job description

Eagle Analytical seeks a Quality Control Chemist to review and maintain analytical chemistry documentation ensuring regulatory compliance and data integrity. You will collaborate with lab operations to support audits, investigations, and continuous improvement across chemistry testing.

The role emphasizes SOP development, method validation review, and documentation quality across UV-Vis, HPLC, and GC-MS platforms. A strong eye for detail is essential.