02 Nov
|
ITC_Labs
|
Panchkula
02 Nov
ITC_Labs
Panchkula
Job Description: LC-MS Officer – Quality Control (Testing Laboratory)Job Title
LC-MS Officer – Quality Control (QC)
Department: Quality Control / Analytical Testing Laboratory
Designation: LC-MS Analyst / Officer
Reporting To: QC Manager / Laboratory Manager
1. Job Purpose
To perform qualitative and quantitative analysis of pharmaceutical, food, chemical, environmental, and other testing samples using Liquid Chromatography–Mass Spectrometry (LC-MS/MS), ensuring accurate, reliable, and reproducible analytical results in compliance with approved testing methods, SOPs, and applicable regulatory requirements.
2. Key Responsibilities and DutiesA. Instrument Operation
- Operate, maintain, and troubleshoot LC-MS/MS instruments.
- Perform routine instrument startup, shutdown, tuning, calibration, and system suitability checks.
- Prepare and optimize LC-MS/MS analytical methods.
- Monitor instrument performance and ensure proper functioning of LC, autosampler, column, and mass spectrometer.
- Maintain instrument logbooks and usage records.
B. Sample Preparation and Testing
- Perform sample preparation, extraction, filtration, dilution, and cleanup.
- Prepare mobile phases, buffers, standards, and working solutions.
- Perform qualitative and quantitative analysis using LC-MS/MS.
- Analyze samples for impurities, residues, contaminants, and active pharmaceutical ingredients (APIs), as applicable.
- Ensure proper sample identification, handling, storage, and traceability.
C. Method Validation and Verification
- Perform analytical method validation and verification.
- Evaluate parameters such as:
- Accuracy and precision.
- Linearity and range.
- LOD and LOQ.
- Specificity and selectivity.
- Recovery.
- Robustness.
- Matrix effect.
- Perform calibration curve preparation and evaluation.
D. Quality Control and Documentation
- Follow approved SOPs and testing procedures.
- Review chromatograms, mass spectra, calibration curves, and analytical data.
- Ensure compliance with GLP, GMP, ISO/IEC 17025, and applicable regulatory requirements.
- Maintain analytical worksheets, raw data, instrument records, and test reports.
- Report any out-of-specification (OOS), out-of-trend (OOT), or abnormal analytical results to the supervisor.
- Maintain data integrity according to ALCOA+ principles.
E. Instrument Maintenance
- Perform routine cleaning and preventive maintenance of LC-MS/MS.
- Maintain vacuum system, ion source, capillary, and other instrument components.
- Identify instrument-related problems and coordinate corrective maintenance.
- Maintain records of breakdowns, repairs, and preventive maintenance.
3. Technical Skills Required
- Hands-on experience with LC-MS/MS instruments.
- Knowledge of ESI and APCI ionization techniques.
- Understanding of MRM, SIM, and full-scan acquisition modes.
- Knowledge of chromatographic separation and mass spectrometry principles.
- Experience with software such as:
- Analyst.
- MassLynx.
- LabSolutions.
- Xcalibur.
- SCIEX OS.
- Knowledge of method development, validation, and troubleshooting.
- Good understanding of analytical chemistry and laboratory practices.
4. Qualification and Experience
Educational Qualification:
- M.Sc. in Analytical Chemistry / Organic Chemistry / Pharmaceutical Chemistry.
- M.Pharm in Pharmaceutical Analysis.
- B.Pharm or B.Sc. Chemistry may be considered depending on experience and laboratory requirements.
Experience:
- 1–3 years of relevant experience in LC-MS/MS testing is preferred.
- Freshers with relevant practical instrument training may also be considered.
5. Regulatory and Quality Requirements
The LC-MS Officer should have knowledge of:
- ISO/IEC 17025:2017.
- GLP and GMP requirements.
- ICH guidelines, where applicable.
- NABL requirements, where applicable.
- Data integrity and ALCOA+ principles.
- Laboratory safety and chemical handling procedures.
- OOS investigation and corrective and preventive action (CAPA).
6. Key Performance Indicators (KPIs)
- Accuracy and reliability of analytical results.
- Timely completion of assigned samples.
- Instrument uptime and maintenance.
- Compliance with SOPs and quality procedures.
- Proper documentation and data integrity.
- Successful completion of system suitability and calibration checks.
- Minimization of analytical errors and repeat testing.
7. Overall Responsibility
The LC-MS Officer is responsible for conducting LC-MS/MS analysis, ensuring instrument performance, maintaining accurate analytical records, following laboratory quality procedures, and generating reliable test results within the specified turnaround time.
Pay: ₹30,000.00 - ₹40,000.00 per month
Perks:
- Provident Fund
Work Location: In person
📌 LCMS OFFICER -QUALITY CONTROL (Panchkula)
🏢 ITC_Labs
📍 Panchkula