Quality and Regulatory Intern

Elephas is a Madison, WI based biotechnology start-up company working to build an instrument platform that will inform how clinicians treat cancer patients around the world. We are seeking a Quality Assurance Intern who is looking to join a group of motivated people driven to providing hope to cancer patients globally.

We are looking for someone who is actively pursuing a career in Quality Assurance or Regulatory Affairs. The ideal candidate will be self-motivated, eager to learn, and comfortable working in a fast-paced and highly collaborative environment. This is a great opportunity to gain practical, hands-on experience in a growing company.

What Will You Do?

• Provide QA/RA support to Research and Development and Operations departments in support of new initiatives, products and services


• Support implementation of continuous improvement projects for the enterprise Quality Management System (eQMS)


• Draft Standard Operating Procedures (SOPs) and product development documentation


• Assist in planning efforts of internal and external audits


• Help create and deliver employee training documents in support of the eQMS

What Will You Need?

• Be a junior or senior student actively pursuing a STEM degree


• Have a commitment and passion for product compliance, quality, and safety


• Have the ability and desire to read, understand, and interpret regulations


• Computer proficiency with Microsoft Office Suite


• Strong analytical, critical-thinking and problem-solving skills


• Detail oriented with strong organizational skills


• Excellent verbal, interpretation, and written communication skills


• Strong interpersonal skills and the ability to work cross-functionally

Nice To Have

• Familiarity with the requirements of the FDA Quality System Regulation 21 CFR Part 820 and ISO 13485 Quality Management System - Medical Devices 

Benefits

• Practical experience with varied business activities


• Shadowing, mentoring, and training with experienced and accomplished professionals


• Competitive compensation


• Flexible schedule


• Collaborative and supportive work environment