Quality Assurance and Control for the Biotechnology Industry Certificate (BQC)
2019-2020
Type: Career, Certificate (C1)
Special admissions requirement
Division: STEM and Education
Training in Quality Assurance and Quality Control (QA/QC) is a desired qualification in the Biopharmaceutical industry. This program is designed for the chemist, biochemist, or biologist already working in the biotechnology field but new to quality assurance and control. This program focuses on the quality requirements for the production and control of biologics and drugs and the differences between quality control and quality assurance and their interaction with manufacturing. Students will develop a thorough understanding of regulatory compliance and good manufacturing practices by reviewing regulatory documentation and performing standard quality control tests in a laboratory setting. This program will provide entry level qualification for those interested in pursuing a career in QA/QC.
The following background is required for this program: either completion of a baccalaureate degree in life sciences, successful completion of credits toward a life sciences baccalaureate degree equivalent to junior status (minimally 8 credits of general chemistry, 8 credits of general biology, and 12 credits of additional laboratory sciences), or completion of an associate degree in the life sciences and enrollment in a 4-year life sciences program.
If you have questions related to program admissions or applications, please contact info@northshore.edu or call 978-762-4188.
If you have program advising related questions, please contact biotech@northshore.edu or call 978-762-4048.
First Year
Fall
| BQC201 | Introduction to Quality Assurance/Quality Control for Drugs and Biologics | 3 |
| BQC271 | Good Manufacturing Practices | 3 |
| Total Credit Hours: | 6 |
Spring
| BQC273 | Advanced Quality Assurance/Quality Control for Drugs and Biologics | 3 |
| BQC275 | Regulatory Compliance for Drugs and Biologics | 3 |
| Total Credit Hours: | 6 |
Summer
| BQC203 | Environmental Health and Safety | 3 |
| PHI120 | Medical Ethics | 3 |
| Total Credit Hours: | 6 |
Requirement Notes
BQC275: Passing this course with a C or better is required for successful completion of the Quality Assurance/Quality Control for Biotechnology industry certificate.
Program Note
Communication and Mathematics proficiency required to graduate.
See guided pathway sheets for advising information specific to your area of focus.
Total Credit Hours: 18
Program Student Learning Outcomes
- Interpret research or operational data.
- Test and evaluate quality of materials or finished products.
- Record research or operational data.
- Maintain and calibrate laboratory or technical equipment.
- Prepare information or documentation related to legal or regulatory matters. Inspect areas for compliance with sanitation standards.
- Monitor operational procedures in technical environments to ensure conformance to standards. Prepare operational reports.
- Develop collaborative relationships between departments or with external organizations. Train personnel in technical or scientific procedures.
Occupational Skills Required
- Generate and maintain lab records.
- Design and generate biotechnology lab experiment protocols using references, protocols and literature.
- Execute biotechnology experiments by following SOPs and lab safety regulations. Interpret and report results of biotechnology lab experiments.
- Use and maintain biotechnology lab equipment.
- Use computers, internet and software tools to search for information and present an idea or results.
Most Common Linked Occupation Title – All Education Levels
- Quality Assurance Specialist
- Quality Control Specialist