Quality Control Analyst

HPLC Analyst – Job Responsibilities (Pharmaceutical Industry)

Position: HPLC Analyst

Department: Quality Control (QC)

Key Responsibilities

• Perform analysis of raw materials, in-process samples, finished products, stability samples, and cleaning validation samples using HPLC and other analytical instruments.
• Operate, calibrate, maintain, and troubleshoot HPLC systems from leading manufacturers such as Shimadzu Corporation
• Conduct assay, dissolution, related substances, impurity profiling, content uniformity, and method verification testing as per approved specifications.
• Prepare mobile phases, diluents, standard and sample solutions as per analytical procedures.
• Review chromatograms and ensure data integrity compliance (ALCOA+ principles).
• Maintain analytical records, laboratory notebooks, instrument logbooks, and test reports in compliance with cGMP and GLP requirements.
• Perform system suitability testing and ensure instruments are functioning within specified limits before analysis.
• Participate in OOS (Out of Specification), OOT (Out of Trend), deviation, and laboratory investigation activities.
• Support analytical method validation, verification, transfer, and stability studies.
• Coordinate with QA and Production departments for timely sample testing and release activities.
• Ensure adherence to SOPs, regulatory guidelines, and laboratory safety practices.

Qualification

• B.Sc./M.Sc. (Chemistry), B.Pharm, or M.Pharm.
• Experience in handling Waters, Agilent, Shimadzu, or Thermo HPLC systems in a pharmaceutical QC laboratory.

Key Skills

• HPLC/UPLC Operation & Troubleshooting
• Chromatographic Analysis
• Dissolution Testing
• Method Validation & Transfer
• cGMP / GLP Compliance
• Data Integrity (ALCOA+)
• OOS/OOT Investigation
• Documentation & Regulatory Compliance

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