Quality Control Associate
A quality control (QC) associate carries out testing and analysis to ensure that biomedical research studies and biomedical products meet specifications and regulatory guidelines. QC associates work in quality control laboratories and in biomanufacturing environments, using complex instrumentation and laboratory equipment to conduct tests and analyses that are used in product quality regulations or scientific research studies. Because the products being developed or manufactured directly impact people’s lives, strict Food and Drug Administration regulations must be followed and documented at every step. In the manufacturing of pharmaceutical products, companies are required to follow SOPs (standard operating procedures) and every step of every process must have a traceable, written record. QC associates are responsible for this documentation. The QC associate performs analytical tests, gathers and assesses data from those tests and writes documentation and reports.
QC associates often are employed by biomanufacturing or biopharmaceutical companies when products are created in sterile, or “clean room,” environments. The product might be a vaccine, a medicine or an enzyme used in food production. Opportunities for employment also are available at agricultural organizations that develop genetically modified foods, such as drought-resistant crops, and at energy companies that are developing and manufacturing cleaner fuels, such as bioethanol and methane. Finally, opportunities are available in the chemical industry and in industrial settings such as paper-and-pulp and textile manufacturers where biotechnology is being used to reduce the environmental impact of manufacturing.
First and foremost, emphasis on science disciplines during high school is important. After high school, a two-year Associate Degree in Applied Science (AAS) from a community college is one path to a career as a QC associate. The areas of specialization might include agricultural, biotechnology, industrial pharmaceutical or bioprocess technology. If you choose to attend a four-year college or university, a Bachelor of Science (B.S.) degree in chemistry or biology will provide a solid foundation. You also could choose a more targeted degree at a four-year college or university, such as biochemistry, microbiology or biopharmaceutical science.
The general entry-level salary range for a validation specialist is $40,000 to $50,000 per year. Salary information is current as of April 2010.