Definition of occupation
The Quality Control Analyst role is junior to the mid-career position. It requires an excellent understanding of the work processes related to how the products or services are produced. A person in this role typically adds value by monitoring and assessing product manufacturing or testing practices to identify critical variances that may decrease the quality of the product or data. The Quality
Control Analyst also conducts routine and non-routine tests on the raw materials, products, or samples at various manufacturing stages. They are often involved in reviewing and creating new Standard Operating Procedures (SOPs) to deal with new equipment, manufacturing methods, or testing processes within the laboratory or manufacturing facility. A Quality Control Analyst will compile data, reviewing it for inaccuracies, abnormalities, or unusual trends which are reported to the appropriate parties within the required deadlines, if identified.
From time to time, staff in this role may be requested to do ad hoc investigations as part of internal or external audits in to assess the probability or confirmation of deviances or nonconformances. If Quality Control Analysts find critical deviances, they collaborate in multidisciplinary teams to reduce the possibility of a loss of product quality.
These processes relate to establishing customer quality requirements for product, service, and other relevant regulatory standards. It is essential that competency and training requirements and standard work processes are maintained in order to prove quality at the product and service levels. When suspected deviance to work processes and product and service quality is detected, the quality methodology requires review for corrective action for any deviances and elements of noncompliance. To achieve consistent quality, numerous tools and techniques like Internal Audits, Statistical Process Controls, root cause analysis, cause and effect diagrams, control charts, Pareto charts, and flow charts may be used. Quality Control Analysts are also responsible for releasing batch products or data approval after confirming the batch or data quality. Documenting product information to allow for an audit trail when and if required in the future is critical.
Quality Control Analysts may work for Canadian biotechnology organizations of different sizes and in various biotechnology areas, such as:
- Food Processing
- Health Care Laboratories
- Human and Animal Health
- Life Sciences
- Medical Devices
- Natural Resources
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