PROFFESIONAL SUMMARYDetailed-oriented quality driven Compliance specialist with 5+ years of experience working in cGMP (Good Manufacturing Practices) clean room (clinical research lab) to ensure the quality of standard care implementation by critical thinking and continuous improvement by problem-solving skillset.SKILLS* Quality Compliance skills: worked on ISO 9001, Regulatory guidelines on 21 CFRs: 1271, 211, 11, 312. Thorough knowledge on FACT requirements for cell therapy products (Immune Effector Cell products). Familiar with DPH and Join Commission.* Technical skills: Proficient in Microsoft Office (Power-point, Excel and Word) Wordpress, Chemsketch, Chemdraw * Soft skills: Problem-Solving / continuous improvement, critical thinking, team player, detailed oriented, decisionmaking,...
Compliance specialist at BILH