Regulatory Business System Analyst

4 days ago


Summerville, South Carolina, United States Thorne Research Full time
Job Title: Regulatory Business System Analyst

We are seeking a highly skilled Regulatory Business System Analyst to join our team at Thorne Research. As a key member of our organization, you will play a critical role in ensuring the compliance of our business systems with regulatory requirements.

Key Responsibilities:
  • Interpret business goals and develop solutions to meet regulatory requirements
  • Provide application support and troubleshoot reported issues
  • Manage user access and security for regulated software
  • Perform system data integrity and 21 CFR Part 11 compliance audits
  • Maintain the validated state of regulated software
Requirements:
  • 3+ years of experience in a Business/Technical analyst role in an FDA regulated environment
  • 1-3 years of experience in validating computer systems
  • Experience in an FDA regulated environment and familiarity with Quality Management processes, systems, and terminology
  • Experience with software development life cycle and Quality Management, Laboratory Information Management, Learning Management, Manufacturing, and Electronic Batch Records software systems
What We Offer:
  • Competitive compensation
  • 100% company-paid medical, dental, and vision insurance coverage
  • Company-paid short- and long-term disability insurance
  • Company-paid life insurance
  • 401k plan with employer matching contributions up to 4%
  • Gym membership reimbursement
  • Monthly allowance of Thorne supplements
  • Paid time off, volunteer time off, and holiday leave
  • Training, professional development, and career growth opportunities
  • A safe and clean work environment

At Thorne Research, we are committed to providing personalized health solutions, cutting-edge home health test technology, and superior supplements. We own every step of our business, from R&D to product delivery and customer service. Join our team and be part of a company that values diversity and is committed to creating an inclusive environment for all employees.


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