Quality Control Chemist - Regulatory Compliance

BioSpace; Houston (TX); On-site; USD 70,000 - 95,000; Full time

Job summary

Eagle Analytical is seeking a Quality Control Chemist to review and maintain analytical chemistry records, ensuring compliance with cGMP, cGLP, ISO 17025, A2LA, and USP standards. The role works with laboratory operations to maintain data integrity across testing functions.

The ideal candidate will have a chemistry degree, experience in regulated labs, and strong knowledge of HPLC, HPLC-MS/MS, GC-MS, and UV-Vis, with attention to detail and documentation accuracy.

Qualifications

• Bachelor's degree in Chemistry or related field.
• Experience in regulated labs (ISO 17025, cGMP, cGLP) preferred.
• Experience reviewing GMP/GLP documentation and quality investigations.
• Strong attention to detail and data integrity.
• Experience with analytical instrumentation and data review.

Responsibilities

• Review and approve analytical chemistry documentation and quality records.
• Ensure compliance with QMS, SOPs, and regulatory standards.
• Support inspections, audits, and accreditation assessments.
• Write, review, and approve SOPs and quality records.
• Review test methods and validation documentation (HPLC, UV-Vis, GC-MS).
• Maintain data integrity, traceability, and quality investigations.
• Contribute to internal audits and CAPA processes.
• Assist in creating quality manuals and procedures.

Skills

Analytical chemistry

HPLC

HPLC-MS/MS

GC-MS

UV-Vis

GMP/GLP

Data integrity

Documentation review

MS Office

Education

Bachelor's degree in Chemistry

Bachelor's degree in Biochemistry

Tools

SOPs

Quality Management System

Job description

Eagle Analytical is seeking a Quality Control Chemist to review and maintain analytical chemistry records, ensuring compliance with cGMP, cGLP, ISO 17025, A2LA, and USP standards. The role works with laboratory operations to maintain data integrity across testing functions.

The ideal candidate will have a chemistry degree, experience in regulated labs, and strong knowledge of HPLC, HPLC-MS/MS, GC-MS, and UV-Vis, with attention to detail and documentation accuracy.