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Quality Control and Assurance

Quality Control and Assurance
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Interested in perfecting the systems and procedures of cutting-edge research and production?

Making a biotechnology product involves meeting specifications for precision and safety. Many of these products are consumed by people and animals, or are distributed into their environment. For example, in the quality control step, a close eye is kept on what should be and what is going into a particular drug. Quality Assurance requires the product to meet certain standards and specifications. Quality Control and Quality Assurance are commonly known as "QC" and "QA." Testing and standards are the key to QC and QA, and the real core of this work is to be sure that things are being done right. These are the people who ensure that products are what the labels say they are.

QC and QA Job Examples

Woman Reviewing Lab Sheet

Validation Technician
An entry level technician develops, prepares and revises test validation procedures and protocols to make sure that the process and product meet internal and industry standards. These technicians analyze information, compare that information to the standards, write reports, and propose recommendations for changes. They maintain validation files for company products.

An entry-level validation technician will be a high school graduate and generally requires on the job training or an associate degree from a community college. This job is a good fit for those who have a systematic approach to life.

Validation Engineer
This person calibrates and validates equipment systems and assists in the selection, specification, and negotiation equipment purchases. He or she maintains documentation about qualification and validation and serves as an information resource for validation technicians, contractors, and vendors.

An entry-level validation engineer requires a Bachelor of Science degree or an equivalent, such as an associate degree with on the job training.

Woman Performing Test

Quality Control Analyst
A QC Analyst conducts routine and non-routine analysis of raw materials (ingredients), such as ethanol or a cancer fighting drug. These Analysts compile data for test procedures and report abnormalities. They also review data obtained for compliance with specifications, to be sure that processes and products meet with company and industry approval. They revise and update standard operating procedures and make sure that everyone has clear instructions on how to do their jobs. They may also perform special projects with analytical and instrument problem solving.

An entry-level QC Analyst requires an associate degree or a Bachelor of Science in a related area, as well as on the job training.

Woman Using Microscope

Quality Control Engineer
This person maintains and revises standards for processing materials into partially finished or finished products. She or he designs and implements methods and procedures for inspecting and testing. Also, QC Engineers conduct evaluations that make sure that products are on target, and prepare documentation for inspection testing.

An entry-level QC Engineer will typically have a Bachelor of Science in a related field, possibly a specialized certificate, and get on the job training in quality control systems.

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