Sr. Analyst, Quality Trust & Compliance

The role of QTC Analyst, Senior is primarily focused on overseeing compliance for product release launch activities and post-launch processes. You will be responsible for ensuring adherence to regulatory requirements and Quality Management System (QMS) standards. Additionally, you will play a key role in leading improvement projects to foster continued growth. As a Senior QTC Analyst, you will serve as a primary point of contact for the product release team, providing guidance and support. Your responsibilities will include reviewing and approving in-process tasks related to product and service provision, as well as developing and overseeing the training of Analysts on the QTC product release team. You will also act as a subject matter expert on the Software Development Life Cycle process. In this role, you will be tasked with developing, writing, and revising controlled Validation Deliverables to support continuous improvement efforts and ensure compliance with procedures related to product release. You will provide ad hoc training to Operations staff on compliance procedures and maintain validation documentation in the QMS according to company procedures. Furthermore, you will participate in Root Cause Analysis meetings, assist with Corrective Actions/Preventive Actions for product discrepancies or failures, and support the Governance unit in preparation for External Audits related to product release. Your role will also involve performing Quality Control reviews on controlled documents such as SOPs, Work Instructions, and Policies within the QMS. To be successful in this position, you should have a M.S. degree with a minimum of 2 years of related experience or a BS/BA degree with a minimum of 4 years of related experience. Certification in Quality Assurance or Regulatory Affairs is preferred. You should possess substantial knowledge of FDA regulations, international regulatory standards, and best practices in the industry. Experience in a regulated environment, particularly within the clinical trial industry, IRT, or CRO, is highly desired. Strong communication, organizational, and interpersonal skills are essential for this role. You should also have strong decision-making abilities, project management skills, and attention to detail. The position requires working in a fast-paced, cross-functional team environment, so collaboration and development skills are key. Being proactive, enthusiastic, and having high work ethics are qualities that will contribute to your success in this role. Experience in developing SOPs for quality assurance and compliance, as well as proficiency in Microsoft Office applications and Adobe Acrobat Professional, are also necessary skills for this position.,