Regulated QC Chemist — ISO 17025 & GMP Compliance

BioSpace; Houston (TX); Sur place; USD 70 000 - 100 000; Plein temps

Résumé du poste

Eagle Analytical is seeking a Quality Control Chemist to review and maintain analytical chemistry documentation, ensuring compliance with cGMP, cGLP, ISO 17025, and USP standards. The role supports the Quality Management System, audits, and method validation across UV-Vis, HPLC, HPLC-MS/MS, GC-MS, and related analytics.

The candidate will ensure data integrity, review investigations and CAPAs, and collaborate with cross-functional teams to drive continuous improvement in chemistry testing

Qualifications

• Bachelor's degree in Chemistry or related field and experience in regulated lab environments preferred.
• Experience with GMP/GLP documentation and quality investigations is desirable.
• Strong attention to detail and data integrity are essential.
• Experience interpreting ISO 17025, cGMP, cGLP, USP, and A2LA standards is advantageous.
• Excellent written and verbal communication skills are required.

Responsabilités

• Ensure compliance with company SOPs and Quality Management System.
• Interpret/regulatory standards (ISO 17025, cGMP, cGLP, USP, A2LA).
• Support regulatory inspections, audits, and assessments.
• Write/review/approve SOPs, forms, and quality records.
• Review methods and docs for chemistry testing (HPLC, HPLC-MS/MS, GC-MS, UV-Vis).
• Review lab test reports, validation protocols/reports.
• Ensure data integrity, accuracy, traceability.
• Review/approve quality investigations (OOS, NCR, DV, CAPA, change controls).
• Evaluate root causes and corrective actions.
• Create audit findings and corrective actions.
• Support internal audits and routine walk-throughs.
• Manage quality documentation storage/retention.
• Prepare training materials and support continuous improvement.
• Assist in maintaining quality manuals/procedures.

Connaissances

Attention to detail

Regulatory compliance

Analytical chemistry

Written and verbal communication

Cross-functional teamwork

Data integrity

GMP/GLP knowledge

HPLC/GC-MS/UV-Vis

Documentation review

Formation

Bachelor's degree in Chemistry

Bachelor’s degree in Biochemistry or related field

Outils

Microsoft Office

Electronic document management systems

Description du poste

Eagle Analytical is seeking a Quality Control Chemist to review and maintain analytical chemistry documentation, ensuring compliance with cGMP, cGLP, ISO 17025, and USP standards. The role supports the Quality Management System, audits, and method validation across UV-Vis, HPLC, HPLC-MS/MS, GC-MS, and related analytics.

The candidate will ensure data integrity, review investigations and CAPAs, and collaborate with cross-functional teams to drive continuous improvement in chemistry testing