Job Abstract

The Sr. Quality Analyst, FDA Regulated Manufacturing will be part of a team of four, consisting of the site QA manager, one QA specialist and two senior QA specialists.

• Is responsible for oversight of quality and regulatory compliance for product manufacturing activities.
• Works to identify and reduce regulatory, accreditation, and compliance risk by continuous monitoring and evaluating current facility policies and practices to ensure compliance is built into the operational systems.
• Oversees manufacturing compliance by making interpretations and developing executive summaries of regulatory and compliance information, maintaining registration information, communication with external regulatory and accreditation agencies.
• Communicates and works effectively with leadership to take necessary actions to mitigate identified risks.
• Is accountable for the effective implementation of the Quality Management System (QMS) and serves as a subject matter expert on the policies, processes and procedures of the QMS by developing a broad knowledge of the practice, business and technology as it relates to product manufacturing.