Biontech Ag - Gaithersburg, MD
posted 3 months ago
As a Specialist II in QA Operations at BioNTech, you will play a crucial role in ensuring the quality and compliance of our manufacturing processes. Your primary responsibility will be to provide Quality Assurance support across various stages of production, including raw materials, in-process materials, and final products. You will be actively involved in resolving manufacturing issues, ensuring adherence to Good Manufacturing Practices (GMP), and maintaining the integrity of our operations in cleanroom and laboratory environments. Your expertise will be essential in conducting quality walk-throughs, performing batch documentation reviews, and overseeing the packaging and shipping processes. You will also support the deviation and corrective action systems, ensuring timely investigations and implementation of corrective measures. This position requires a proactive approach to identifying compliance risks and collaborating with various departments to uphold our commitment to quality and safety in the development of immunotherapies. In this role, you will be expected to engage in hands-on QA support, providing oversight during tech transfers and manufacturing operations. You will be responsible for the disposition of incoming materials, including patient apheresis material, and ensuring that all products are manufactured in compliance with regulatory guidelines. Your contributions will extend to training new hires and supporting the tracking of site quality metrics, which are vital for continuous improvement. You will be part of a dynamic team that values scientific rigor, innovation, and a passion for improving health outcomes worldwide. Your ability to communicate effectively and work independently will be key to your success in this fast-paced environment.