Stephen MacMichael

Document Control Coordinator - Quality Assurance

Role
Quality Assurance Associate at Tavanta Therapeutics
Location
Philadelphia, PA, US
LinkedIn followers
500 followers

About Stephen MacMichael

Chemical Engineer with seven years of experience in pharmaceuticals, biologics, and cell and gene therapies. Significant experience in document management and data review of quality and analytical-related data, including physical and digital databases for patient files, training records, and clinical manufacturing. Strong expertise with computer skills and analytical problem-solving skills.

Experience

  1. Quality Assurance Associate

    Tavanta Therapeutics

    Aug 2023 — Present · King of Prussia, PA, US

    Supported TAVT-119, an amlodipine besylate gel in development for pain associated with anal fissure, and TAVT-45, a novel oral suspension of abiraterone acetate- Oversaw the Quality Assurance documentation management systems of SOLABS and Microsoft Office for the entire company- Reviewed protocols, analytical methods, and specification documents used in making drug products in Phase 2/3- Outlined and wrote standard operating procedures with relevant department heads to ensure proper training for on and off-site personnel

Education

  • Villanova University

    Bachelor of Science (B.S.), Chemical Engineering

    2015 — 2020

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Stephen MacMichael — Quality Assurance Associate at Tavanta Therapeutics in Philadelphia, PA, US | Unifers