QA/Analytical Development Subject Matter Expert -AI Model Evaluation

Overview

Freelance, project-based role evaluating AI-generated pharmaceutical content for scientific, technical and regulatory accuracy, completeness and compliance. This is an evaluation role, not a laboratory position.

What you'll do

• Evaluate AI-generated pharmaceutical content for accuracy, completeness, consistency and compliance with industry standards.
• Review scientific and regulatory information on quality systems, manufacturing, validation, submissions, development and compliance activities.
• Analyze whether AI-generated conclusions are supported by scientific principles, regulatory expectations and industry best practices.
• Identify errors and inconsistencies, including unsupported claims, technical inaccuracies, missing context and flawed reasoning.
• Validate information against relevant FDA requirements, GMP regulations, ICH guidelines and accepted pharmaceutical industry practices.
• Provide expert feedback explaining findings and recommending technically accurate corrections.
• Apply project-specific evaluation criteria, scoring guidelines and quality standards.
• Complete independent evaluations on designated online platforms within established project timelines.

What you'll need

• Minimum of 4 years of professional experience in Quality Control, Analytical Development, Analytical Chemistry, Pharmaceutical Testing or related laboratory functions.
• Bachelor's degree or higher in Chemistry, Pharmaceutical Sciences, Pharmacy, Biochemistry, Biotechnology, Microbiology, Life Sciences or a related discipline.
• Experience supporting pharmaceutical laboratory operations within regulated environments.
• Experience with analytical method development, validation, transfer or routine testing activities.
• Familiarity with pharmaceutical analytical instrumentation such as HPLC, UPLC, GC, LC-MS, UV, dissolution systems or related technologies.
• Understanding of laboratory investigations, including OOS, OOT, deviations and root cause analysis.
• Knowledge of FDA regulations, GMP requirements and relevant ICH guidelines.
• Experience reviewing scientific and manufacturing documentation.
• Ability to critically evaluate technical and regulatory information.
• Strong analytical, research and problem-solving skills.
• Excellent written English communication skills.
• Ability to work independently and follow detailed review instructions.
• Comfortable working within a task-based freelance engagement model.

Nice to have

• PharmD, MS, MBA, PhD or other advanced scientific credentials.
• Experience with analytical method validation and transfer programs.
• Experience supporting stability testing and shelf-life studies.
• Expertise with chromatographic and spectroscopic techniques.
• Experience conducting OOS, OOT and laboratory deviation investigations.
• Knowledge of USP, EP and compendial testing requirements.
• Experience supporting regulatory submissions through analytical documentation and data review.
• Experience collaborating with Quality Assurance, Manufacturing, Regulatory Affairs and Product Development teams.
• Experience with technical writing, laboratory reports or scientific document review.
• Familiarity with AI evaluation, data annotation or quality review activities.
• Experience with AI model evaluation, large language models (LLMs), research or structured quality assessments.

Details

• Work arrangement: remote; primary location United States, with professionals outside the US considered if they have substantial U.S. pharmaceutical industry experience.
• Engagement: project-based independent contractor, paid hourly at $25-$50 USD (compensation varies by specialization, experience and task complexity).
• Schedule: variable and assignment-based; work may be irregular or intermittent, and hours and future assignments are not guaranteed.
• Selection may require screening questions and evaluation exercises before project selection.