Pharma QC/Analytical AI SME (Remote, Contract)

Volga Partners; United States; A distancia; USD 28.000 - 69.000; A tiempo parcial

Descripción de la vacante

Volga Partners seeks an experienced pharmaceutical QC/Analytical Development SME to evaluate AI-generated content for accuracy, regulatory compliance, and scientific validity. You will review analytical, manufacturing, and quality-related content, identify errors, and provide expert feedback grounded in regulatory expectations.

The role is freelance, project-based with remote work eligibility from the United States, compensating $25–$50 USD/hour based on experience and project requirements.

Formación

• Minimum 4 years of professional experience in Quality Control, Analytical Development, Analytical Chemistry, Pharmaceutical Testing, or related lab functions.
• Bachelor's degree or higher in Chemistry, Pharmaceutical Sciences, Pharmacy, Biochemistry, Biotechnology, Microbiology, Life Sciences, or related discipline
• Experience with pharmaceutical laboratory operations within regulated environments
• Experience with analytical method development, validation, transfer, or routine testing activities
• Familiarity with analytical instrumentation such as HPLC, UPLC, GC, LC-MS, UV, dissolution systems
• 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

Responsabilidades

• Evaluate AI-generated pharmaceutical content for accuracy, completeness, consistency, and regulatory compliance.
• Review scientific and regulatory information related to quality systems, manufacturing, validation, submissions, development, and compliance activities.
• Analyze technical reasoning and determine if AI conclusions are supported by scientific principles and regulatory expectations.
• Identify errors, inconsistencies, missing context, and flawed reasoning in content.
• Validate information by referencing FDA requirements, GMP regulations, ICH guidelines, and industry practices.
• Provide expert feedback with clear findings, opportunities for improvement, and recommended corrections.
• Support AI quality improvement by applying project-specific evaluation criteria and quality standards.
• Complete independent evaluations using designated online platforms within project timelines.

Descripción del empleo

Volga Partners seeks an experienced pharmaceutical QC/Analytical Development SME to evaluate AI-generated content for accuracy, regulatory compliance, and scientific validity. You will review analytical, manufacturing, and quality-related content, identify errors, and provide expert feedback grounded in regulatory expectations.

The role is freelance, project-based with remote work eligibility from the United States, compensating $25–$50 USD/hour based on experience and project requirements.