Quality Auditor - Scientific

This contractor opportunity is for a Quality Auditor - Scientific - II (Associate) within the Global Development Quality Operations – Drug Product (GDQ Ops) organization. The GDQ Ops team provides critical quality oversight for manufacturing, testing, and release activities associated with clinical-stage Drug Products, ensuring continuous GMP-compliant clinical supply for both internally and externally manufactured supplies. Working under the direction of GDQ-Ops Supervision, the contractor will play a pivotal, supportive role in quality assurance oversight, product release, document management, and compliance projects within a dynamic, fast-paced R&D environment. Responsibilities Perform independent quality review and approval of batch records, testing data, and related documents to make independent batch release or reject decisions. Conduct independent auditing, review, and approval of complex document types, including deviations, investigations, analytical method validations, method transfers, and certificates of analysis. Support compliance activities such as site readiness, health authority audits, and Corrective and Preventive Actions (CAPAs). Collect, prepare, and analyze data to support quality system metrics and planning initiatives. Perform document management activities, including cataloging records for long-term storage according to retention policies. Develop, write, technically edit, or review procedures and other standard documents under Good Manufacturing Practice (GMP) guidelines. Support projects aimed at continuous quality improvement, utilizing project management skills as needed. Provide meeting coordination, facilitation, scribing, and clear communication across teams. Ensure strict compliance with applicable GMP regulations, ICH guidelines, and company policies. Education Bachelor degree (B.S.) in an appropriate Science or Engineering discipline (such as engineering, chemistry, biology, biochemistry, or microbiology). Recent graduates can be considered for this role. Experience A minimum of 3 years of experience is preferred. Experience must be within the pharmaceutical, biotechnology, chemical, medical device, or a closely related industry. Demonstrated knowledge of R&D or clinical supply areas, processes, and preferred drug product manufacturing and testing. Background in one or more functional areas such as quality control, quality assurance, laboratory, manufacturing, production, equipment/facilities management, or regulatory. Strong foundational knowledge and expertise in Good Manufacturing Practice (GMP) or related drug regulations. Additional Information Candidates must possess strong leadership, collaboration, teamwork, negotiation, and workload management skills to handle rapidly changing R&D needs. Proven ability to work cross-functionally and across various sites with all levels of staff and management is required. Qualified candidates must be proficient with the Microsoft Suite (Word, Excel, PowerPoint, Teams) and show a strong ability to adapt to learning other electronic day-to-day work systems. #J-18808-Ljbffr WorkLlama, Inc.