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.

• 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

• 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

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

• Practical experience with varied business activities
• Shadowing, mentoring, and training with experienced and accomplished professionals
• Competitive compensation
• Flexible schedule
• Collaborative and supportive work environment