Quality Control
Quality Control (usually known as QC) is an important part of the Pharmaceutical and Medical Device production and supply process. It often means different things in different contexts. For example, QC in a Pharmaceutical manufacturing company often refers to lab-based QC analysis of raw materials, intermediates and finished products, using different chemistry techniques (e.g. HPLC, GS, MS, LC-MS, wet chemistry or other materials characterisation techniques). Within a Biopharmaceutical company, QC may also include Microbiology (e.g. bioburden and endotoxin, testing environmental samples or water samples) or Biochemistry (e.g. ELISA, western blotting and SDS-PAGE). In different settings, QC may refer to other inspections and checks outside of the lab, including checking different components, inspecting packaging materials, and ensuring the correctness of shipments.
QC often works in close collaboration with Quality Assurance (QA). QA is defined as a procedure or set of procedures intended to ensure that a product or service under development (before work is complete, as opposed to afterwards) meets specified requirements. QA is sometimes expressed together with QC as a single expression, quality assurance and control (QA/QC).
In order to implement an effective QC program, an enterprise must first decide which specific standards the product or service must meet. Then the extent of QC actions must be determined (for example, the percentage of units to be tested from each lot). Next, real-world data must be collected (for example, the percentage of units that fail) and the results reported to management personnel. After this, corrective action must be decided upon and taken (for example, defective units must be repaired or rejected and poor service repeated at no charge until the customer is satisfied). If too many unit failures or instances of poor service occur, a plan must be devised to improve the production or service process and then that plan must be put into action. Finally, the QC process must be ongoing to ensure that remedial efforts, if required, have produced satisfactory results and to immediately detect recurrences or new instances of trouble.
Typical Job Titles include – QC Assistant, QC Scientist, QC Technician, QC Inspector
Key Skills and Experience
- Most QC roles require a degree in an analytical science, whether Chemistry, Biochemistry, Microbiology, Pharmaceutical Chemistry, or similar. However, this is not always essential
- Knowledge of analytical techniques (e.g. HPLC, GC, MS, LC-MS, GC-MS etc)
- Ability to complete and process complex documentation and data
- Knowledge of GMP / GLP
- Ability to stay focused, even if undertaking routine repetitive tasks
Salary Levels
Entry-level QC roles generally start in the region of £17k - £18k and move up relatively quickly, especially if you have a degree. QC teams are often divided into levels (1, 2, 3 etc), with clearly defined salary bandings. Generally, an experienced QC Scientist who undertakes project leadership duties (e.g. method development, stability etc) will earn something in the region of £25k - £28k. Then, if you go down the supervisor / manager route, a QC Manager salary might start around the “mid 30s”. QC is not necessarily the most highly paid part of the Life Science industries, but it is varied and very important.
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.
