Analytical Chemist – QC & GMP Lab Expert

Aurobindo Pharma USA, Inc.; Durham, Northern (NC, KY); Hybrid; USD 80,000 - 90,000; Full time

Job summary

Aurolife is seeking a Chemist C to perform analysis, review, and investigations while maintaining GLP in the laboratory. The role emphasizes test execution on materials across the product lifecycle, with emphasis on accuracy and regulatory compliance.

Candidates should have a BS in a scientific field, 4–6 years pharma experience, and 3–5 years in analytical testing or QC in generics. Strong knowledge of USP/ICH/FDA guidelines is required.

Qualifications

• Minimum BS with scientific field required.
• Chemistry background preferred for the role.
• 4–6 years in pharma with 3–5 years in analytical testing.
• QC experience in generics advantageous. Knowledge of GMP/GLP and USP/ICH/FDA.

Responsibilities

• Perform sampling, physical and chemical tests on raw materials, APIs, in-process and finished products using HPLC, GC, UV-Vis, IR and other QC instruments.
• Plan and inventory test reagents and ensure supplies are adequate for timely testing.
• Execute testing to meet established timelines with supervision as needed.
• Record data accurately and maintain clear documentation.
• Prepare and review test procedures, SOPs, and protocols.
• Calibrate laboratory instruments with supervision.
• Troubleshoot investigations under supervisor direction.
• Ensure compliance with regulatory requirements (cGMP, cGLP, housekeeping and safety).
• Review analytical documents and maintain GLP in the lab.
• Handle QAMS document management and other duties as assigned.

Education

Minimum BS with Scientific field

BS with Chemistry is one of the subjects would be preferable

Minimum 4-6 years experience in pharmaceuticals

3-5 year experience in Analytical testing

3 years QC experience in Generic Pharmaceutical industries would be preferable

Job description

Aurolife is seeking a Chemist C to perform analysis, review, and investigations while maintaining GLP in the laboratory. The role emphasizes test execution on materials across the product lifecycle, with emphasis on accuracy and regulatory compliance.

Candidates should have a BS in a scientific field, 4–6 years pharma experience, and 3–5 years in analytical testing or QC in generics. Strong knowledge of USP/ICH/FDA guidelines is required.