Analytical Chemist II — GMP/GLP QC & Instrumentation

Acrotech Biopharma Inc; Durham (NC); On-site; USD 65,000 - 90,000; Full time

Job summary

Aurolife seeks a Chemist B to conduct routine analytical testing and instrumentation in a GLP-compliant wet laboratory. You will handle sampling, data recording and ensure accuracy using HPLC, GC, UV-Vis and IR among other QC instruments to support product quality and regulatory standards.

You will plan testing workflows, prepare reagents, review procedures, calibrate instruments, and ensure compliance with cGMP/cGLP, contributing to a robust generic pharma portfolio.

Qualifications

• BS in a scientific field required, Chemistry preferred.
• 3-5 years in the pharmaceutical industry with 2-4 years in analytical testing.
• Experience in generic pharmaceuticals is a plus.
• Knowledge of Good Documentation Practices and USP/ICH/FDA guidelines.

Responsibilities

• Perform sampling, physical/chemical tests and assays on materials and products using wet chemistry and instrumental techniques.
• Plan reagents inventory and ensure supplies are available for testing.
• Execute testing to meet deadlines; document data and outcomes clearly.
• Prepare and review test procedures, SOPs and protocols.
• Calibrate and maintain laboratory instruments; troubleshoot under supervision.
• Comply with safety, cGMP, cGLP and regulatory requirements; appropriate documentation.

Skills

BS with Scientific field

Chemistry background

Pharmaceutical experience 3-5 years

Analytical testing 2-4 years

Generic pharma experience

GDP knowledge

USP/ICH/FDA knowledge

Fast learner

Education

BS in Science

Chemistry background

Job description

Aurolife seeks a Chemist B to conduct routine analytical testing and instrumentation in a GLP-compliant wet laboratory. You will handle sampling, data recording and ensure accuracy using HPLC, GC, UV-Vis and IR among other QC instruments to support product quality and regulatory standards.

You will plan testing workflows, prepare reagents, review procedures, calibrate instruments, and ensure compliance with cGMP/cGLP, contributing to a robust generic pharma portfolio.