Regulatory Compliance Specialist
3 weeks ago
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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