Profile Details

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USD 175 /hr

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Hire Sean M.

United States

USD 175 /hr

Experienced consultant in U.S. FDA pharmaceutical regulations

Profile Summary

Experienced quality systems consultant with a demonstrated history of working in the pharmaceutical, medical device, and pharma/device logistics industries. Skilled in risk management, U.S. FDA GMP requirements, process validation, computer systems validation, critical facilities/equipment/utilities qualification, and project management. Strong quality assurance professional with a Bachelor’s Degree in Chemistry from Marietta College.

Subject Matter Expertise

• ★ Project Management

Services

• Writing
• Research
• Consulting
• Data & AI

Writing Clinical Trial Documentation, Technical Writing

Research Market Research, Gap Analysis, Systematic Literature Review

Consulting Scientific and Technical Consulting

Data & AI Statistical Analysis, Data Processing

Work Experience

President / Senior Consultant

Merrill Group LLC

May 2021 - Present

Education

BSc Chemistry

Marietta College

August 2011 - May 2016

Certifications

• CQE (expected August 2021)

  ASQ

  January 2021 - Present