Quality Assurance and Regulatory Affairs

Overview

Applications open now

The Quality Assurance and Regulatory Affairs (QA/RA) Certificate Program is an interdisciplinary program designed to upskill or reskill aspiring or working professionals interested in expanding their knowledge of how to bring a medical product to market including regulations, quality management systems, risk management, compliance, auditing and inspection metrics, design controls, and best practices. QA/RA employees are critical to designing, running, and reporting the testing required to show medical products comply with quality standards and regulations at each stage of the product lifecycle. QA/RA positions lead hiring demands in biotech, however, nearly 32% of companies surveyed ranked QA/RA openings as the most difficult roles to fill, providing a clear opportunity for upskilling and reskilling.

To meet employer needs, the QA/RA certificate will include access to career-enhancing experiential learning opportunities and mentorship. A partnership including the Colorado Bioscience Institute, and 16+ industry leaders will facilitate an innovative approach to providing participants with opportunities to increase economic mobility in high-demand, high-skill, high-wage occupations. The four courses that make up the certificate will be delivered online and asynchronously with a 3-day, in-person experience hosted by local Denver Metro area companies in the final capstone class. The curriculum is customized with input from our Advisory Board members to meet the QA/RA needs of the local bioscience community. The program provides specialized job training as well as mentorship and job matching activities offered by the Institute.

Admission Requirements:

A BA/BS degree with a minimum GPA of 3.0, four years of experience in a regulated manufacturing environment, or a combination of both higher education and work experience that is equivalent to four years (i.e. a two-year degree and two years of work experience).

Required Courses (12 credits)

• BIOE 4054/5054 – Introduction to Regulatory Affairs
• BIOE4420/5420 – Special Topics: Introduction to Quality Assurance
• BIOE4420/5420 – Special Topics: Post-market Quality Assurance and Regulatory Affairs
• BIOE4420/5420 - Special Topics: Product Lifecycle Capstone

Certificate Partnerships:
Colorado BioScience Institute

Industry Supporters:
Allosource, Cerapedics, DeLeon Research, Inc., Edgewise Therapeutics, Gates Institute, Gates Biomanufacturing Facility, Highridge Medical, KBI Biopharma, Medtronic, Monarch Medical Technologies, Nissha Medical Technologies, Standard Biotools, STAQ Pharma, Terumo BCT, Tolmar, TriSalus Life Sciences, and Umoja Biopharma