Quality Control Associate

Job Purpose:

To perform raw material, in-process, and finished product analysis using validated analytical techniques, ensuring compliance with GMP/GLP guidelines and regulatory requirements.

Key Responsibilities:

• Perform analysis of raw materials, in-process samples, and finished products as per approved specifications, test methods, and protocols.
• Operate, calibrate, and maintain analytical instruments including HPLC, FTIR, and GC .
• Troubleshoot analytical instruments, particularly HPLC systems , and ensure uninterrupted laboratory operations.
• Ensure proper documentation and data integrity in compliance with GMP and GLP guidelines .
• Maintain and update laboratory records, test reports, calibration records, logbooks, and analytical worksheets .
• Utilize server-based chromatography software for data acquisition, processing, and reporting for HPLC and GC systems.
• Ensure compliance with Good Documentation Practices (GDP) at all times.
• Coordinate with QA for out-of-specification (OOS) investigations , deviations, and corrective actions when required.
• Ensure proper handling, labeling, storage, and disposal of samples and chemicals.
• Support internal and external audits by providing required documentation and technical explanations.

Technical Skills & Knowledge:

• Strong operating knowledge of HPLC, FTIR, and GC instruments.
• Hands-on experience in calibration, operation, and troubleshooting of HPLC systems .
• Knowledge of SAP for material management, data entry, or quality-related transactions.
• Proficiency in MS Office applications (Word, Excel, PowerPoint).
• Experience working with server-based chromatography software for HPLC and GC.
• Understanding of GMP, GLP, GDP , and regulatory compliance requirements.

Educational Qualification:

• B.Sc / M.Sc in Chemistry / Analytical Chemistry / Pharmaceutical Sciences or equivalent.

Experience:

• 14 years of relevant experience in a QC laboratory within pharmaceutical / medical device / chemical manufacturing industries.