Quality control (testing finished products) and quality assurance (checking quality during production) both serve essential roles in industrial biotechnology and pharmaceutical manufacturing. These job functions are important for reducing the risk and costs of replacing faulty goods or incorrect results. Companies build a reputation for quality by: a) following regulations such as the US FDA requirements for medical devices and pharmaceuticals, or b) gaining accreditation with a recognized quality standard such as ISO 9001, published by the International Organization for Standardization. A certificate in Quality Systems prepares students for entry level positions as quality inspectors, document control technicians, or quality control or quality assurance technicians, responsible for setting up periodic testing and analysis during both the research and development and the manufacturing processes of biomolecules, pharmaceuticals, or medical devices.
Courses may include:
- General chemistry
- Protein Isolation/Purification
- Analytical Methods
- Safety and Regulatory Compliance
- Quality Control Techniques
- Instrumental Analysis
- Good Manufacturing and Good Laboratory Processes (GMP/GLP)
- Bioreactor/cell Culture Techniques
- Clean Room Operations
- Quality Systems and Auditing Principles
- Technical Writing
- Statistical Process Control
- Math and Computer Science are generally required before or in conjunction with this program.