Analyst – Instrumentation (HPLC)

Key Responsibilities

Analytical Operations

• Perform analysis of samples using HPLC as per validated or standardized methods and ensure completion within defined turnaround time (TAT).
• Ensure accuracy, reproducibility, and reliability of test results.
• Review raw data, chromatograms, and calculations generated by junior analysts or trainees for correctness and completeness.
• Validate analytical results and ensure proper entry, approval, and traceability in LIMS or Sample Management Software.

Documentation & Quality Compliance

• Maintain and update all relevant records, logbooks, and test sheets in compliance with ISO 17025, GLP, and GxP requirements.
• Review and update SOPs, specifications, methods, and ensure implementation of any approved changes.
• Record and report non-conformances, deviations, and OOS/OOT results; ensure timely closure in coordination with QA and Lab Manager.
• Represent the section during internal, customer, and regulatory audits, ensuring readiness and compliance.

Instrument Maintenance & Calibration

• Perform daily operational checks, routine preventive maintenance, and calibration of HPLC systems and supporting sample preparation instruments.
• Coordinate with service engineers for preventive and breakdown maintenance; maintain service reports and calibration certificates.
• Conduct system suitability, performance verification, and ensure instruments are in validated working condition.

Standards & Inventory Management

• Prepare and maintain stock of Certified Reference Materials (CRMs), Standard Reference Materials (SRMs), and working standard solutions as per method requirements.
• Monitor validity, storage conditions, and usage records of standards and reagents.
• Ensure availability and quality of solvents, reagents, consumables, and instrument spares; coordinate with purchase department for replenishment and quality verification.

Training & Supervision

• Train and guide junior analysts or trainees in HPLC operation, sample preparation, troubleshooting, calibration, and safety procedures.
• Ensure adherence to laboratory safety protocols, GLP practices, and 5S principles for efficient workspace organization.

Method Development & Validation

• Support method development, optimization, and validation activities in accordance with ICH, AOAC, or other relevant guidelines.
• Maintain validation protocols, raw data, and summary reports as per documentation standards.
• Contribute to continuous improvement initiatives to enhance analytical accuracy, efficiency, and productivity.

Qualification & Experience

• Education: B.Sc. / M.Sc. / B.Tech. in Analytical Chemistry, Chemistry, or related discipline.
• Experience: 2–5 years of hands-on experience in HPLC analysis in a regulated or accredited laboratory environment (pharmaceutical, food, environment, or chemical testing).