QC Chemist – ISO 17025, cGMP, & HPLC Focus

BioSpace; Phoenix (AZ); On-site; USD 65,000 - 85,000; Full time

Job summary

Eagle Analytical is seeking a Quality Control Chemist in Phoenix to review and maintain analytical chemistry documentation and quality records across cGMP, cGLP, ISO 17025 and USP standards. You will work with lab operations to ensure data integrity and regulatory compliance while supporting audits and continuous improvement.

The role requires a Chemistry-related degree and demonstrated experience with analytical testing methods, method validation, and quality systems.

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.
• Strong understanding of analytical chemistry techniques and instrumentation, including HPLC, HPLC-MS/MS, GC-MS, and UV-Vis.
• Working knowledge of method validation, data review, and laboratory quality systems.
• Experience reviewing GMP/GLP documentation and quality investigations.
• Strong attention to detail and commitment to data integrity and compliance.
• Excellent written and verbal communication skills.
• Ability to work independently while collaborating effectively with cross-functional teams.
• Proficiency with Microsoft Office applications and electronic document management systems.
• ASQ preferred

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 for compliance.
• Review and approve analytical test methods and related documentation for chemistry testing (UV-Vis, HPLC, HPLC-MS/MS, GC-MS).
• 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, DV, CAPA, change controls, customer complaints).
• Evaluate root cause analyses and corrective action plans.
• Create audit finding reports and determine appropriate corrective actions.
• Support and conduct internal audits of quality systems and documentation.
• Perform routine walk-through audits across laboratory departments.
• Manage auditing, storage, and retention of quality documentation and quarantined materials.
• Prepare and maintain quality-related training materials.
• Support continuous improvement initiatives related to quality systems and documentation.
• Assist in creating and maintaining quality manuals, procedures, and other controlled documents.
• Perform additional duties and special projects as assigned.

Skills

Attention to detail

Written and verbal communication

Team player

Self-starter

Education

Bachelor's degree in Chemistry

Bachelor's degree in Biochemistry

Tools

HPLC

HPLC-MS/MS

GC-MS

UV-Vis

MS Office

Electronic document management systems

Job description

Eagle Analytical is seeking a Quality Control Chemist in Phoenix to review and maintain analytical chemistry documentation and quality records across cGMP, cGLP, ISO 17025 and USP standards. You will work with lab operations to ensure data integrity and regulatory compliance while supporting audits and continuous improvement.

The role requires a Chemistry-related degree and demonstrated experience with analytical testing methods, method validation, and quality systems.