Transforming aesthetics with advanced biotechnology solutions
Revance Therapeutics, headquartered in Nashville, Tennessee, specializes in biotechnology with a focus on aesthetic and therapeutic products. Their flagship product, DaxibotulinumtoxinA, is a next-generation neuromodulator designed for both aesthetic and therapeutic applications. Revance has raised ...
Revance offers competitive salaries, equity options, generous PTO, and a flexible remote work policy to support work-life balance....
Revance fosters a culture of innovation and scientific excellence, encouraging employees to contribute to groundbreaking advancements in biotechnology...
Revance • Johnson City, TN
Revance is hiring a Quality Assurance Coordinator to support site Quality Systems by managing deviations and CAPAs. You'll ensure compliance with FDA regulations and maintain inspection-ready documentation. This role requires a Bachelor's degree in Life Sciences or Engineering.
You have a Bachelor's degree in Life Sciences, Engineering, or a related field, and you bring experience in quality assurance within a regulated environment. You are skilled in managing deviations and CAPAs, ensuring compliance with FDA 21 CFR 210/211/11 and ICH Q10. Your expertise in Root Cause Analysis techniques, such as 5-Why, Fishbone, and FMEA, allows you to identify true root causes effectively. You are detail-oriented and understand the importance of maintaining inspection-ready documentation to uphold product quality and data integrity. You thrive in a culture of continuous improvement and accountability, promoting investigative rigor across teams.
In this role, you will lead or support investigations for deviations, out-of-specification (OOS) and out-of-trend (OOT) events, nonconformances, and complaints. You will ensure that all documentation is timely, complete, and compliant with regulatory standards. Your responsibilities will include performing structured Root Cause Analysis to identify underlying issues and developing Corrective and Preventive Actions (CAPAs) that are specific, measurable, and linked to verified root causes. You will analyze and trend investigation and CAPA data to identify systemic issues and recommend process improvements. Additionally, you will ensure that all records meet ALCOA+ data-integrity standards and are ready for inspection. You will collaborate with Manufacturing, Quality Control, and Engineering functions to foster a culture of quality and accountability.
Revance offers a supportive work environment where you can grow your skills and contribute to meaningful projects. You will have the opportunity to work with a dedicated team focused on maintaining high-quality standards in product development. We encourage you to apply even if your experience doesn't match every requirement, as we value diverse perspectives and backgrounds. Join us in our mission to enhance patient care through innovative solutions.
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