Quality Assurance Specialist
Apply Job Type Full-time Description MERIT CRO, Inc. is a global clinical trial endpoint expert specializing in multiple therapeutic areas. We’re committed to making a difference and are seeking talented people to join our team. Collaboration and customer focus are at the core of everything we do. We value diversity and are interested in people with drive, dedication, and creative problem-solving skills. We offer flexible schedules and remote opportunities SUMMARY: Primary functions include collaborating with Operations and the Quality Assurance Manager to maintain and assist with implementing the Quality Management System (QMS). Ensures the compliance of appropriate quality management tools, implements the related process. Performs internal audits and contractor and vendor assessments including qualifications, on-site audits, and maintenance activities. Assists with on-site client audits and provides training and communications on regulatory requirements to MERIT personnel. ESSENTIAL DUTIES AND RESPONSIBILITIES: (Other duties may be assigned.) Understand the EXCELSIOR™ product, protocol and conduct of clinical trials in sufficient detail to be able to adequately discuss, direct and manage task items with the project managers and team members Comply fully with MERIT policies and Standard Operating Procedures (SOPs) Internal audits – conducts internal audits and assists in the development of the internal audit schedule. Client and regulatory on-site visits and audits- assists with scheduling and managing audits as assigned. Vendor and Contractor qualifications and audits – conduct vendor and contractor qualifications and audits including on-site audits, and vendor and contractor maintenance activities. Leads the development, recommendation, review and administration of policies, training and SOPs Provide training for implementation of internal and regulatory requirements Ensure that SOPs are being followed during daily operations: CAPA, deviations, non-conformances, Apply tot his job