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Advanced BioScience Laboratories (ABL) is a biotech corporation headquartered in Rockville, MD, dedicated to providing contract manufacturing and laboratory research services aimed at advancing leading vaccines and therapies from clinical development to the commercial market. ABL leverages decades of pioneering science and manufacturing expertise to drive the development of innovative therapies and vaccines that support the biopharmaceutical industry in their quest to improve public health. The Quality Assurance Specialist II plays a crucial role in supporting QA Operations, ensuring that project objectives are met to a high-quality standard while maintaining compliance with current Good Manufacturing Practices (cGMPs) and relevant US and EU regulations. In this role, the Quality Assurance Specialist II will be responsible for a variety of QA Operations activities, including Lot Disposition, QA oversight on the manufacturing floor, client audits, data review, and supplier quality management. The Specialist will act as a quality resource supporting the GMP organizations across the site, exercising judgment within defined Quality Assurance and Manufacturing procedures to resolve manufacturing issues effectively. The position requires a proactive approach to ensure compliance with cGMPs for clinical manufacturing of investigational biological products, as well as adherence to 21 CFR Parts 210, 211, and 600. Key responsibilities include conducting batch record reviews, supporting project sub-contractors, critically reviewing and approving various GMP documentation, and guiding personnel involved in GMP operations. The Specialist will also act as the first responder for on-the-floor quality issues, documenting all events and investigations, and facilitating immediate corrective actions to ensure right-first-time (RFTP) outcomes. Additionally, the role involves supporting the generation of quality metrics, participating in internal and external audits, and collaborating with cross-functional teams to address facility issues using methodical problem-solving tools. The Quality Assurance Specialist II will report quality deficiencies to supervisors and department heads, ensuring that all activities align with ABL's commitment to quality and compliance.
