Regulatory Compliance Specialist

3 weeks ago


Portland, Oregon, United States Critical Mass Consulting Full time

About Us

Critical Mass Consulting, LLC is a leader in providing expert consulting services to Life Sciences clients. Our team is passionate about helping others and making a difference in the industry.

Job Summary

We are seeking highly skilled consultants to join our team in Portland, OR. As a consultant, you will be responsible for developing and executing commissioning/validation protocols, performing risk analyses, and supporting multiple client sites on validation projects.

Key Responsibilities:

  • Develop and execute commissioning/validation protocols
  • Perform risk analyses
  • Support multiple client sites on validation projects
  • Consult clients on latest industry approaches to commissioning, qualification, and validation
  • Manage medium-small teams and/or projects

Requirements:

  • Bachelor's degree in a life sciences-related field
  • Minimum 2 years of experience working in the pharmaceutical, medical device, or biotech industry
  • Strong understanding of Good Documentation Practices (GDP) and experience working in FDA regulated industries
  • Excellent written and verbal communication skills, emphasizing strong technical writing skills
  • Pass the Transportation Security Administration (TSA) Security Threat Assessment (STA)

What We Offer:

A competitive salary, remote work options, and opportunities for continuous personal development, including support/financing of technical training, mentorship, and development of high-performance teams.



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