Senior QC Chemist - Pharma Stability & Analysis

Aurobindo Pharma USA, Inc.; Durham (NC); On-site; USD 80,000 - 89,000; Full time

Benefits offered by this job

Medical plans

Dental plans

Vision plans

Life Insurance

Disability Insurance

FSA

HSA

401(k) Plan with match

EAP

Job summary

Aurolife seeks a QC Chemist C to perform analytical testing and stability studies, ensuring GLP status in the lab and adherence to regulatory requirements. The role focuses on bench work 80–100% with rigorous data review and documentation.

The ideal candidate has 5+ years in pharmaceuticals, experience in cGMP environments, and familiarity with EMPOWER/LIMS. Inhalation testing experience is preferred; flexible hours may be required.

Qualifications

• BS or MS in Chemistry or Pharmaceutical Sciences, or related field.
• Minimum 5+ years of experience in Pharmaceuticals and Analytical testing.
• Preference shall be given for experience in Inhalation testing on a variety of Inhalation products.

Responsibilities

• Perform in-process, finished product and stability testing using wet chemistry and instrumental techniques (HPLC, UPLC, GC, UV-Vis, IR, Particle Size Analyzer, KF titrator, Bulk Density).
• Plan and execute testing to meet timelines with minimal supervision.
• Assist with preparation or review of Test Procedures, SOPs, Protocols, and CoAs.
• Record data clearly and ensure tests are accurate.
• Maintain calibration of laboratory instruments with minimal direction.
• Assist in troubleshooting and investigations.
• Draft deviation reports as assigned.
• Comply with safety, cGMP, cGLP and documentation requirements.
• Review analytical documents; investigate OOS/OOT deviations.

Skills

EMPOWER/LIMS

QC in generics

cGMP environment

Good Documentation

USP/ICH/FDA guidelines

Team player

Flexible hours

Fast learner

Education

BS or MS in Chemistry or Pharmaceutical Sciences

Job description

Aurolife seeks a QC Chemist C to perform analytical testing and stability studies, ensuring GLP status in the lab and adherence to regulatory requirements. The role focuses on bench work 80–100% with rigorous data review and documentation.

The ideal candidate has 5+ years in pharmaceuticals, experience in cGMP environments, and familiarity with EMPOWER/LIMS. Inhalation testing experience is preferred; flexible hours may be required.