R&D Specialist, Medical Device Stability

Job description

Job Summary The R&D Specialist will work with internal business partners and product development teams to provide stability support. This role is responsible for writing stability protocols/reports, evaluating stability data, performing risk assessment, and supporting process improvements. This position plays a critical role in setting expiration dates for medical devices, drugs, and cosmetics. Responsibilities: Direct stability studies required in support of product claims. Determine the tests and acceptance criteria required for stability in collaboration with testing subject matter experts and product divisions. Support new product development and provide stability requirements. Author and review test stability protocols and reports. Evaluate and trend stability data. Compile technical justifications and data summaries in support of stability claims. Ensure compliance of all data collection activities with applicable regulatory requirements. Participate in the support of internal and external audits. Support process improvement, deviations, CAPA, and OOS investigations. Qualifications: Bachelor of Science in Chemistry, Biology or related field. At least 2 years of experience in...