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.