Manufacturing Compliance Specialist I
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About The Position
The Manufacturing Compliance Specialist I plays a crucial role in ensuring that manufacturing processes adhere to established quality standards and regulatory requirements. This position involves investigating process deviations, proposing and implementing effective Corrective and Preventive Actions (CAPA), and performing on-the-floor batch record reviews. The specialist will monitor and measure the ongoing performance of manufacturing quality systems, ensuring that all operations comply with company policies and regulatory guidelines. In this role, the specialist will determine accurate root causes of deviations and drive investigations to successful resolutions. Building strong interdepartmental relationships is essential, as the specialist will track CAPA and deviation owners to ensure timely completion of actions. The position also requires issuing reports and tracking metrics related to open manufacturing deviations, investigations, excursions, and CAPA. The specialist will keep various quality and efficiency metrics as directed by manufacturing management and facilitate the accurate and timely completion of manufacturing reviews of executed batch records. This includes ensuring that batch records are completed in accordance with company Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs), and customer specifications. Additionally, the specialist will assist in correcting deficiencies found within the documentation reviewed and facilitate discussions on training adequacy and CAPA effectiveness. The role also encompasses regulatory responsibilities, where the specialist must conduct business in a manner that complies with all state, OSHA, and HIPAA regulations. A detailed understanding of FDA, EU, and other regulatory agency requirements is essential for success in this position.
