Shaun B.

Manager, Quality Assurance for Analytical Services (Commercial & Product Development) @The Ritedose Corporation

Columbia, SC, US

Quality Assurance document review and control within the QMS system (Master Control) for laboratory operations, laboratory SOPs, and ensure compliance with relevant regulatory guidance and compendia.• Fully trained and certified auditor of laboratory activities, instrumentation, and documentation procedures as applied to the pharmaceutical industry.• Supervising internal and external (CMO) laboratory functions for routine analytical analysis, method transfers, development, verification, and validations of various Inhalation and 503B injectable pharmaceutical products and associated API’s & raw materials.• Managing analytical method development and validation for global finished product market expansion (EU & ChP)• Managing and designing analytical analyses for method transfers, developments, and validations of various Inhalation and 503B injectable pharmaceutical products and associated API’s & raw materials.• Leading and implementing laboratory investigational techniques for deviations, OOS, and OOT data generated during routine analytical analysis, method transfers, development, verification, and validations of various inhalation and 503B injectable pharmaceuticals and related raw materials (API’s & Excipients).• Creator and reviewer of comprehensive written reports for finished product (internal & external CMO manufacturing) elemental, nitrosamine, & residual solvent impurities risk assessments, ensuring product and excipient compliance with relevant regulatory guidance and compendia.• Responsible for identifying, training, and assigning appropriate personnel or CMO’s for project completion• Laboratory Systems Administrator for Empower data collection system and managing user access for all laboratory instrumentation such as Empower, ICP-MS, TOC, UV/VIS, DSC, KF, IR, balances, pH meters, spectrometer, colorimeter, etc.