Us Food And Drug Administration Work Values

Daily Duties at Us Food And Drug Administration :

TEAM MEMBER/LEADERSHIP: Skilled and knowledgeable in the quality systems base approach concept and the regulations. Conducted and participated in complex team and individual Human and Veterinarian Drug work inspection assignments including clinical investigational drugs, over-the-counter drugs, active pharmaceutical ingredient, adverse reaction, complaints, and pre-approvals. Conducted and Participated in complex independent inspections, complaints, trained others on Biologics work assignments and inspections. Selected to participate as a field investigator on pre-licensing inspections with a Center for Biologics Evaluation and Research Investigator. Demonstrated aptitude in blood banking, plasma center, human tissue, and hospital transfusion services inspections to secure a Biologics Cadre Member position for six years. Performed timely and efficient follow-up investigations to patient and donor-related fatalities Achieved highest level of Biologics Level II Certification available in three years within the agency Completed Blood Banking & Plasmapheresis I/II and Introduction to Inspections of Human Cells (HCT/P) training. Completed Basic Drug School and Active Pharmaceutical Ingredient (API) training. Trained colleagues and in complex team drug inspections. Completed Juice/Seafood Hazardous Analysis & Critical Control Point (HACCP). I indirectly utilized this concept in all program areas due to need to be aware of critical control points in any manufacturing processes.

What they like about Us Food And Drug Administration :

The social vibrance of a hiring firm is very important to you. Your ability to make and maintain friendships there is a critical part of your decision. You would likely be dissatisfied with a workplace that is quiet, cold, or otherwise not particularly social. When you investigate a new hiring company, ask recruiters, managers, and potential co-workers about the social life and opportunities there. This is especially important when you are relocating; moving dramatically alters your social sphere both inside and outside the workplace.

Tags

Leadership, Negotiating, Teamwork, Process analysis , Oral/Interpersonal Communication, Regulatory Compliance, Quality Assurance, Regulatory Affairs, Georgia, BA Chemistry, MA Management courses, Quality Systems, FDA/ICH Guidelines, Process Review, Process Reengineering, Process Improvement, Protocol Execution, Project Management, OD Change Management

Skills

Ecommerce Strategy and digital marketing channels optimization - SEO, SEM, email, affiliates - for high-profile accounts., Sales Support, Software Implementation, Leadership , Negotiating , Leadership , oral/written/interpersonal communication, FDA regulations and guidances, cGMP Trainer, Team Member and Leader

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