Quality Control Chemist — GLP/cGMP Compliance Pro

Aurobindo Pharma USA, Inc.; Durham (NC); On-site; USD 80,000 - 90,000; Full time

Job summary

Aurolife, part of the Aurobindo family, seeks a Qualified Quality Control professional in North Carolina to ensure GLP and cGMP compliance within the QC laboratory. You will oversee audits, CAPA management, and regulatory inspection readiness while supporting data integrity and documentation controls.

Responsibilities include reviewing analytical data, investigations related to OOS/OOT/Deviations, and collaboration with QA, QC, Manufacturing, and Regulatory Affairs to maintain compliance across

Qualifications

• Minimum 4-6 years in pharmaceuticals with analytical testing focus.
• Knowledge of GMP/GLP and good documentation practices.
• Familiarity with USP/ICH/FDA guidelines and quality systems.

Responsibilities

• Ensure GLP and cGMP compliance and data integrity across QC labs.
• Review analytical docs, audits, CAPA, and regulatory inspections readiness.
• Manage documentation systems and archival/retrieval of records.
• Support investigations related to OOS/OOT/Deviations and CAPA.
• Review equipment qualification, calibration, and maintenance records.
• Collaborate with QA, QC, Manufacturing, and Regulatory Affairs to ensure compliance.
• Analyze RM/PM/SFG/FG/stability samples and calibrate laboratory instruments.

Skills

Pharma experience

Analytical testing

Quality systems

Documentation

Regulatory knowledge

Education

BS in Chemistry

BS in Science

Job description

Aurolife, part of the Aurobindo family, seeks a Qualified Quality Control professional in North Carolina to ensure GLP and cGMP compliance within the QC laboratory. You will oversee audits, CAPA management, and regulatory inspection readiness while supporting data integrity and documentation controls.

Responsibilities include reviewing analytical data, investigations related to OOS/OOT/Deviations, and collaboration with QA, QC, Manufacturing, and Regulatory Affairs to maintain compliance across