Definition of occupation
Usually, a senior practitioner holds the Quality Control Specialist role with an excellent understanding of the nature of the business in which they operate. A person in this role typically adds value by taking charge of quality assurance activities.
Generally, the Quality Control Specialist’s responsibilities include the quality management activities across the whole product value chain. They begin with the review of and participation in updating quality assurance policies, ensuring the Quality Management System’s (QMS) efficiency, and identifying risk areas where quality losses may occur. The Quality Control Specialist also collaborates with numerous process owners to determine production, process, or product issues and then facilitates teams to develop and implement solutions.
Typically, the Quality Control Specialist would act as the company’s subject matter expert or process owner responsible for ensuring the company has a body of knowledge and quality management tools available. Teams can then use these tools to initiate different interventions to ensure that product or service quality is delivered. Depending on the company’s size, the Quality Control Specialist may be responsible directly or indirectly for a team of quality management analysts.
In addition to strong technical knowledge and quality management skills, the Quality Control Specialist needs to interact and collaborate with different staff levels, from a grassroots level to senior executive levels. In this relationship, they advise, influence, and direct people without positional power. Strong interpersonal skills and team skills are essential.
These processes relate to establishing customer quality requirements for product and service standards, competency training requirements, standard work processes to be maintained, and quality proven at the product and service levels. When deviance to work processes and product and service quality is detected, the quality methodology expects intervention to correct any deviances and elements of noncompliance. At the same time, preventive measures must be taken to avoid the same noncompliance occurring again. To achieve consistent quality, incumbents use numerous tools and techniques like Internal Audits, Statistical Process Controls, root cause analysis, cause and effect diagrams, control charts, Pareto charts, and flow charts. They are often also responsible for releasing batch products after the quality of the batch has been confirmed. Also, adequately documented product information is essential to allow for an audit trail when required in the future.
Quality Control Specialists play a significant role in Canadian biotechnology organizations of different sizes (small, medium, large) and in various biotechnology areas, such as:
- Food Processing
- Human and Animal Health
- Life Sciences
- Medical Devices
- Natural Resources