GMP, Quality assurance associate II

School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations. Be You. The Office of Regulatory Affairs & Quality (ORAQ) is looking for a GMP, Quality Assurance Associate II, to join our team. In this role, you will help ensure that the products, materials, and processes used in Duke’s GMP programs meet the highest standards of quality and compliance. You will play a key part in supporting the Marcus Center for Cellular Cures (MC3) GMP Facility—an innovative environment where your work directly impacts clinical research and patient-focused manufacturing. You will work with a wide range of partners across manufacturing, engineering, validation, and quality functions. Your days will include work on supporting and evolving quality systems, including supporting investigations, building tools to analyze and assess quality metrics, supporting robust supplier qualifications systems, inspection readiness planning and training, and guiding teams on GMP expectations. You’ll also help shape continuous improvement efforts and support inspections, giving you a front-row seat to the full lifecycle of GMP operations. Education · Bachelor’s degree required Minimum Requirements: · 5 years of experience in a GXMP or similar regulated environment. · Experience training users in implementing Quality Systems. · Prior laboratory experience preferred. · Experience preparing for external audits and/or site visits. · Experience reviewing raw materials, supplies, and manufactured products for acceptability. · Master’s or PhD may substitute for experience · Or any equivalent combination of relevant education and/or experience. Preferred Qualifications: · Bachelor’s degree in life sciences or a related field. · Experience serving as final QA signature for release of raw materials or finished products. · Experience representing QA in cross-functional settings and reporting back to the department. · Experience with validation and/or technical quality engineering support of manufacturing operations (required). · Master’s or PhD may substitute for experience except for validation/technical quality engineering requirements. Other Requirements: · Proficient knowledge of GLP, GMP, and/or GTP. · Strong leadership, organizational, and time-management skills. · Ability to train staff effectively. · High attention to detail in document review. · Strong interpersonal, verbal, and written communication skills. · Ability to work independently or collaboratively in a fast-paced environment. · Adaptability to shift priorities. · Problem-solving skills and a sense of urgency in completing tasks. This position is Onsite. The work is performed on-site or at a designated assignment location. Be Bold. You will: · Review and support change control for development, modification, and manufacturing process changes. · Represent QA in project meetings and provide quality guidance. · Write, revise, and review SOPs to support compliant operations. · Lead or support continuous improvement initiatives across GMP programs. · Track and trend quality metrics to identify areas of concern. · Assist with inspections and manage quality-related matters during audits. · Review and guide deviations and investigations, collaborating with end users to resolve issues. · Train staff on GMP principles, investigations, and root cause analysis. · Review product records for release of clinical trial materials and components, when required. · Participate in multiple programs across various development phases. · Conduct environmental monitoring and assist with data analysis, when required. · Conduct audits under the supervision of the Lead Auditor and generate audit reports. Choose Duke. At Duke, you’ll join a community committed to advancing science, improving health, and supporting groundbreaking clinical research. The Office of Regulatory Affairs & Quality plays a vital role in ensuring that Duke’s GMP programs operate with excellence, integrity, and compliance. You’ll be part of a collaborative, mission-driven environment where your expertise directly contributes to the success of innovative cellular and gene therapy programs. Working within the Marcus Center for Cellular Cures (MC3), you’ll support cutting-edge manufacturing that impacts real patients and drives the future of regenerative medicine. Duke offers a culture of learning, growth, and teamwork—where your contributions are valued and your professional development is supported. Anticipated Pay Range: Duke University provides an annual base salary range for this position as USD $86,714.00 to USD $140,129.00. Duke University considers factors such as (but not limited to) scope and responsibilities of the position; candidate's work experience, education/training, and key skills; internal peer equity; as well as market and organizational considerations when extending an offer. Your total compensation goesbeyond the dollars on your paycheck. Duke provides comprehensive and competitive medical and dental care programs, generous retirement benefits, and a wide array of family-friendly and cultural programs to eligible team members. Learn more at: Equal Opportunity Employer: Duke is an Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender,gender expression, gender identity, genetic information, national origin, race, religion, sex (including pregnancy and pregnancy- related conditions), sexual orientation, or military status. Duke aspires to create a community built oncollaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values. Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and reasonable accommodation(s) can be requested with Duke Access and Accommodations Services (email: ; phone: 919-668-1267).