QA Specialist
Quality Assurance (QA) is a vital function within all Pharmaceutical and Medical Device companies. Job titles within the QA area can vary a great deal across different companies, with titles including QA Coordinator, QA Associate, QA Officer, QA Specialist, QA Officer and QA Scientist, then progressing to QA Manager, QA Lead etc. The QA terms, especially at junior-to-intermediate level, are often quite interchangeable.
The QA team is typically responsible for ensuring that the quality standards and systems followed in the manufacture of drugs is in compliance with Good Manufacturing Practice (GMP) and meets the specific quality standards laid out in the company’s Quality Management System (QMS). A QMS will include quality standards for internal audits, deviations, change controls, corrective actions, quality review reports, clean room monitoring, batch record review, and external documentation reviews.
A pharmaceutical QA professional’s responsibilities will include analysing the production process of pharmaceuticals, identifying areas where errors prevail, root cause analysis, observing every activity, monitoring the drugs being manufactured or packed for visible defects, testing the drugs (or at least interpreting the data from lab-based QC analysis), noting down observations gathered from the quality control process, and accepting or rejecting batches of drugs on the basis of samples (Batch Release). Quality Assurance teams will often be divided into different QA groups, with some more focused on batch record review while others are more involved in non-conformance investigations and SOP (Standard Operating Procedure) updates.
Skills and Experience required to become a Quality Assurance Specialist
- Science degree (this is not always essential)
- Experience gained in a GMP / ISO environment
- QA processes and systems
- Diplomacy
- Batch record processing
- Ability to multi-task
- Several years’ previous experience in a QA role
Salary Levels
Quality Assurance salaries can vary enormously depending on what specific duties the person will be undertaking. If the QA role is a relatively entry-level or administrative one, focused on batch review or entry and processing of Quality Assurance documents / data, salaries could be in the £18k - £24k range. QA salaries can then increase steadily once you start to specialise in a particular QA area, especially if this means getting involved in hosting / conducting internal or external audits, continuous improvement initiatives, team leadership, or training. Quality Assurance offers a varied and interesting career path and you could earn up to £40k in a non-management role and significantly more than this once you are in a management-level QA position.