Quality Control Executive

HPLC Analyst Job Description (QC Department)

An HPLC Analyst in a Quality Control (QC) department is responsible for performing high-performance liquid chromatography (HPLC) testing on raw materials, in-process samples, and finished products to ensure they meet quality and purity standards. This role is crucial for maintaining the integrity and safety of pharmaceutical, food, or chemical products.

Key Responsibilities

Sample Analysis:

Perform routine and non-routine analysis of samples using HPLC systems. This includes sample preparation, method execution, and data acquisition. Method Development & Validation:

Develop and validate new HPLC analytical methods or optimize existing ones for new products or processes. This involves creating and executing protocols to demonstrate the method's accuracy, precision, and robustness. Instrument Maintenance:

Conduct routine maintenance, calibration, and troubleshooting of HPLC equipment and other lab instruments to ensure their proper functioning and data accuracy. Documentation & Reporting:

Meticulously document all analytical work, including raw data, results, and observations, in lab notebooks or LIMS (Laboratory Information Management System). Prepare and review reports, certificates of analysis (CoAs), and other quality documents. Compliance & Audits:

Ensure all work is performed in compliance with

Good Manufacturing Practices (GMP) ,

Good Laboratory Practices (GLP) , and standard operating procedures (SOPs). Participate in internal and external audits to demonstrate compliance. Data Integrity:

Maintain the integrity of all data generated. Review and approve data from junior analysts and ensure that all records are complete, accurate, and traceable. Troubleshooting & Investigation:

Investigate out-of-specification (OOS) or out-of-trend (OOT) results, identify the root cause, and implement corrective and preventive actions (CAPA).

Required Qualifications

Education:

A bachelor's or master's degree in Chemistry, Biochemistry, or a related scientific field. Experience:

2-5 years of experience working with

HPLC

and other analytical techniques in a QC, R&D, or manufacturing environment. Experience in a cGMP-regulated industry is highly preferred.