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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.

Stevenage

Stevenage is a town in Hertfordshire approximately 35 miles north of London.  Although there is evidence of a Roman settlement, Stevenage grew very slowly over the centuries.  However, in 1946 Stevenage was designated Britain’s first “New Town” which meant six neighbourhoods being developed to help resolve the UK’s post-war accommodation problems.  Opened by the H.M. the Queen in 1959, Stevenage's pedestrianised town centre was the first traffic free shopping zone in Britain.   From a business point of view, Stevenage has become a centre for Life Sciences thanks to the Stevenage Bioscience Catalyst which aims is to support the next generation of pharma and biotech companies by offering  access to equipment and facilities and in so doing placing the UK bioscience sector at the forefront of worldwide biomedical innovation.  More recently Stevenage has become famous for the annual rock and pop festival held at Knebworth.

Famous people born in Stevenage:  Lewis Hamilton,  F1 motor racing world champion and Ian Poulter, professional golfer