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Quality Control Analyst Career Profile

Quality Control Analyst

A Quality Control (QC) analyst is responsible for all of the testing that is performed in the lab. This includes all relevant analytical techniques: HPLC, GC, UV-Vis, Dissolution, Particle sizing, degradation etc, depending on the specifics of the lab and product to be tested. There is teamwork, scheduling and logbooks to be kept supporting the quality of the materials being tested. There will be tests required on raw materials, in-process samples and finished products usually.

Key Responsibilities of the Quality Assurance Analyst


  • Achieves competency in laboratory methods and procedures as set out by the company
  • Trains other QC analysts in laboratory methods and procedures when required
  • Performs Microbiological and/or Chemical testing activities in relation to method validation and technical transfer activities so as to ensure that all methods meet ICH, CFR and USP guidelines
  • Executes validation, operation, maintenance, calibration and troubleshooting of equipment and its associated software
  • Writes, executes, reports and reviews IQ/OQ and PQ protocols so as to ensure that all relevant equipment is qualified for cGMP use
  • Performs routine and non-routine Microbiological and/or Chemical testing activities during Plant production phase
  • Reviews laboratory test results when required
  • Ensures that testing and results approval are completed within agreed turnaround times
  • Writes and reviews laboratory TMs, SOPs and WIs as directed by company policy
  • Ensures QC activities are carried out in compliance with product licence commitments, cGMP and company quality standards
  • Is an active member of the QC group and provide assistance with other group activities as required and communicates relevant issues to the QC Team Leader
  • Anticipates and plans for future requirements in the area
  • Deals with non-conformances/ deviations in an accurate and timely manner