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.
Scotland
Scotland is a country that is part of the United Kingdom. Covering the northern third of the island of Great Britain.
The global cell and gene therapy market was valued at $6.68 billion in 2019 and is expected to reach $13.23 billion in 2023 at a CAGR of 24.10% (Ref. BusinessWire).Also in 2019, a joint report from The Alliance for Regenerative Medicine (ARM) and the BioIndustry Association (BIA) stated that the UK is a leading source of innovation and development of advanced therapy medicinal products (ATMPs) in Europe. These products, which include gene therapies, cell therapies, and tissue-engineered products, are intended to augment, repair, replace, or regenerate organs, tissues, cells, genes, and metabolic processes within the body. Scotland has a strong reputation in research & translational development in these fields and is rapidly growing a vibrant cluster of spin-out therapeutic companies, increasing clinical trials of new Advanced Therapy Medicinal Products (ATMPs) as well as expanding its manufacturing capability.
Scotland also has established expertise in developing and manufacturinghuman vaccines(the global market projected to grow to $96b by 2023 according to Business Research Company) and animal vaccines (worth $9b by 2025 – Global Market Insights, Inc).
Scotland’s profile and contribution towards the growth of the UK ATMP sector is increasing rapidly. A strengthening supply chain is supporting new advanced therapy applications – fuelled by world-leading academic expertise in cell & gene therapy and regenerative medicine,. With a forward focus on translation, specialised clinical trials, and GMP manufacture and analysis, Scotland is growing a vibrant infrastructure to support end-to-end development of advanced therapies.
Human and animal vaccine development is a strength in Scotland represented by companies such as Valneva, Neogen, and GalvMed as well as the Moredun Research Institute. In addition to Valneva’s Covid-19 Vaccine programme, Scotland’s supply chain made huge contributions to the development of Covid-19 vaccines including Merck BioReliance, Charles River, Symbiosis, SGS, Ingenza & ReproCell Europe.
One of the largest life sciences clusters in Europe, Scotland is home to a range of multinationals and small and medium enterprises (SMEs) with a strong track record of creating and growing startups.
Scotland has comprehensive supply chains and world class manufacturing expertise supplying chemical and healthcare equipment, pharmaceutical services, medicines, vaccines and diagnostics to the world.
The cluster continues its rapid expansion building on a strong industry base, leading universities with a thriving entrepreneurial culture and close collaborations across industry, academia, the National Health Service and government.
Scotland is a great place to further your career in life sciences. If you are a looking for pharmaceutical jobs in Scotland, scientific careers in Scotland or want to discuss cell therapy, gene therapy, ATMP, medical device, technology, biotech or pharmaceutical job opportunities in Scotland, give our Next Phase team a call. The Scottish area is continuing to expand as a centre for jobs in science, process development, technology, software development, project management, informatics, quality, reg affairs and supply chain.
At Next Phase we help people find new jobs in life sciences across the UK, Europe and USA. This page lists some of the job opportunities in Scotland, and if you give us a call we can also talk to you about other scientific jobs, pharmaceutical career opportunities and the latest updates in cell and gene therapy and ATMP development in the Scottish area.
