We are seeking a Quality Operations Associate in Houston, TX.

This person will conduct study document review, data reporting, site management issues, and issue resolution.Assist in the development and implementation of infrastructure including SOPs, Master Documents, Work Instructions, and Training. Position does have supervisory responsibilities

Additional duties will include:

• Prepare and conduct GCP/GDP training as applicable.
• Support Director Quality Operations with FDA Inspections including readiness training.
• Maintain an up-to-date understanding of all issues and changes in regulatory compliance activities at FDA and other applicable compliance groups.
• Support quality initiatives as outlined in company Quality Management Plan
• Support quality deliverables associated with company infrastructure including but not limited to SOP development/review, Master Document development/review, company Work Instruction development/review and training development/review.
• Maintain a high level of knowledge and understanding of all protocols, study plans, and other applicable study documents.
• Support the facilitation of internal quality audits including but not limited to internal site audits and regulatory audits.
• Good working knowledge of Clinical Research procedures and guidelines.

 EDUCATION and/or EXPERIENCE

• Bachelor’s degree, preferably in a scientific/healthcare field with minimum 5-7 years of experience in related area.
• Knowledge of FDA regulatory requirements is required.
• Familiar with a variety of the concepts, practices and procedures in clinical research.
• Strong writing, presentation and communication skills.
• Work effectively and efficiently to handle multiple task simultaneously with strong organizational skills.
• Ability to facilitate a teamwork philosophy