We are currently recruiting for a Quality Assurance Analyst who will be responsible for completing QA and Regulatory Affairs activities ensuring compliance to company SOPs, as well as client and regulatory agency requirements. Essential duties include, but are not limited to: preparing checklists for use by QA Analyst/Specialist for review of Study Documentation and Regulatory Binders; assisting Quality Manager with preparing for and hosting client visits; conducting audits reviewing and interpreting regulations to ensure compliance. Also assists with training, scheduling workload of staff, and managing staff in the absence of Sr. Quality Manager.
Bachelor's Degree or nursing qualification, plus four or more year's related experience in clinical research or Quality Assurance required. Candidate must be proficient with MS Office Suite of products focusing on Excel, and other internet and word processing software. Candidate must have the ability to travel up to 30% on a routine basis.