Quality Assurance Specialist

Aerogen Pharma is a US based clinical-stage specialty pharmaceutical company with a mission to develop inhaled drug/biologic and device combination products. At Aerogen Pharma, our advanced science starts with a deeply human purpose: improving outcomes and access to medicines for preterm infants and other critically ill patients with life-threatening respiratory diseases around the globe. We bring together patient and healthcare system understanding, pharmaceutical innovation and advanced aerosol delivery technology to develop inhaled therapies designed specifically for the unique needs of the world’s most vulnerable patients. We are a growing company at an exciting and dynamic stage in our development. Our portfolio includes APC-0101, an aerosolized surfactant currently in phase 3 clinical trial and APC-0201, a synthetic surfactant currently in pre-clinical development. Each of these products are designed to treat respiratory distress syndrome in premature infants and together set a foundation for exciting future opportunities. Joining Aerogen Pharma means becoming part of an experienced, dedicated team working collaboratively to advancing respiratory and critical care through innovation. Our “We Care” culture is reflected in how we work together creating a welcoming, inclusive environment where people make time to support one another, share their expertise and ensure every team member feels connected and empowered to contribute. At Aerogen Pharma, the work you do every day will have direct impact to the advancement of meaningful development programs as you collaborate with experienced leaders and experts across the pharmaceutical and medical technology industries What is the role? The Quality Specialist supports Quality Operations through the Quality Oversight of Manufacturing, Packaging, and Labeling Operations Batch Record Review, Product Review and Approvals, Supplier Management Oversight and quality records review and management. This position also supports continual process improvement for Quality Management Systems. What are the

key responsibilities
? Batch Record Review Perform comprehensive review of manufacturing, packaging, and labeling batch records to ensure accuracy, completeness, and compliance with cGMP and regulatory standards Verify critical process steps, test results, deviations, yields, and equipment cleaning logs are properly documented Identify documentation errors, inconsistencies, and missing information, and coordinate timely corrections with Manufacturing, QC, and QA. Ensure identified Quality Events, Deviations, OOS results, and other quality issues are appropriately documented, investigated, and resolved using the applicable Quality System processes and tools. Support lot disposition activities by preparing QA documentation packets for final review Data Review & Validation Review and validate batch data, including electronic quality systems (EQMS) and EMR records, for completeness and accuracy Participate in internal audits and support external regulatory inspections Assist in investigating deviations, nonconformances, change controls and CAPAs as needed Recommend process and documentation improvements to enhance compliance and efficiency Support QA oversight of Contract Manufacturing Organizations (CMOs) and suppliers Review vendor-provided documentation and ensure compliance with quality agreements. Coordinate with procurement and operations to address vendor-related quality issues. Quality Management System (QMS) Support Ensure GMP processes are implemented in the QMS for the entire product lifecycle Ensure all SOPs and controlled documents are current, approved, and maintained in accordance with applicable document control requirements. Aid and provide support for training activities What education and experience are required? Bachelor’s degree in pharmacy, chemistry, biochemistry, microbiology, engineering, life sciences, or a related discipline. At least 3+years of pharmaceutical, biotechnology, or similarly regulated industry experience, including at least 2 years in GMP Quality Assurance, manufacturing, or quality control. Direct experience reviewing executed batch records and supporting product disposition is strongly preferred. Experience overseeing CMOs or suppliers is preferred, particularly for a company that outsources GMP manufacturing. Familiarity with applicable requirements and guidance, including 21 CFR Parts 4, 210/211, 600/601 and 820 (QMSR), EudraLex Vol. 4 & Annexes, MDR 2017/745, ISO 13485 and 14971, data-integrity expectations, and relevant ICH quality guidelines. Experience with electronic systems such as Veeva, TrackWise, MasterControl, SAP, Oracle, or electronic batch-record platforms is desirable. What key skills will make you great at the role? Strong working knowledge of pharmaceutical cGMP, Good Documentation Practices, ALCOA+ data-integrity principles, and applicable regulatory requirements. Ability to review man