Quality Assurance Specialist

Job description

About Aerogen Pharma: 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 Vendor Management • 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 manufacturing, packaging, labeling, cleaning, and testing records for accuracy, completeness, compliance, and lot-disposition readiness. • Experience supporting deviations, nonconformances, root-cause investigations, CAPAs, change controls, audits, and regulatory inspections. • Proficiency with electronic Quality Management Systems (eQMS) and electronic batch or manufacturing records, including review of electronic data and audit trail and electronic Document Management Systems (eDMS). • Ability to provide quality oversight of CMOs and suppliers, including reviewing vendor documentation, monitoring quality-agreement compliance, and resolving quality issues. • Exceptional attention to detail and the ability to identify documentation errors, inconsistencies, compliance gaps, and potential product-quality risks. • Sound judgment and integrity, with the confidence to escalate issues that could affect product quality, patient safety, data integrity, or regulatory compliance. • Strong analytical and problem-solving skills, including the ability to evaluate information from multiple records and contribute to effective investigations. • Clear written and verbal communication skills, with the ability to document observations and communicate requirements in an inspection-ready manner. • Strong organization, collaboration, and follow-through when managing competing priorities and working with internal teams, CMOs, and suppliers. • Preference for location near San Mateo California Why Aerogen Pharma? As a key member of Aerogen Group, the global market leader in high-performance aerosol drug delivery, Aerogen Pharma is at a pivotal point in the company's life cycle. With plans to expand and centralize our US hubs over the next two years, we offer an environment where you can thrive professionally and learn from driven industry leaders in drug development and commercialization, inhaled devices, and neonatology. We foster an inclusive culture that empowers you to contribute to the transformation of Neonatal care, where potential is recognized, and professional development is encouraged. Equal Employment Opportunity Aerogen Pharma is committed to providing equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable law. Salary Range and Benefits Salary Range for this position is estimated at $88,000-$105,000 and will depend on the candidate's skills, qualification and experience. The role is eligible for a performance-based incentive bonus and comprehensive benefit package including Medical, Dental, and Vision Coverage, 401k Retirement, Enhanced Global Life Insurance, Paid Time Off (15-20 days tenure related), Global EAP Program, Short-Term Disability and FMLA Benefits. The company reserves the ri