Stability Specialist

Target PR Range: 23-33/hr DOE Role Description The Specialist Stability is an individual contributor role that provides critical support to Product Quality Teams (PQTs) by managing stability programs for late-stage clinical and commercial products. You will serve as a primary author of regulatory filing sections, organize and analyze product quality and stability data, and support GMP inspections across sites. This role requires strong expertise in GMP compliance, data management, and cross-functional collaboration. You will also contribute to business process improvements by authoring SOPs and supporting the development of electronic data management tools such as Spotfire and SHINY applications. Roles & Responsibilities Build, monitor, and manage product stability studies in GMP quality systems (e.g., Veeva, LIMS, SampleManager)Author and maintain GMP technical documents and stability reports in compliant systemsProvide stability data reports using electronic reporting tools (e.g., Spotfire, SHINY)Collate, review, verify, and archive GMP stability and product quality dataCoordinate stability study starts and sample requests with global teamsParticipate in audits and inspections across multiple sites, ensuring readiness and complianceCollaborate with offshore teams to support Annual Product Reviews and Annual Reports of Minor ChangesMentor and train staff, sharing expertise to strengthen team capabilities Basic Qualifications And Experience Doctorate Degree in a Life Sciences or Engineering discipline ORMaster's degree and 3 years of Quality, Operations, Scientific, or Manufacturing experience ORBachelor's degree and 5 years of Quality, Operations, Scientific, or Manufacturing experience Functional Skills Must-Have Skills: Thorough understanding of GMP requirements, US FDA, and ICH regulationsStrong scientific data management and organizational skills with exceptional attention to detailProven technical writing skills with ability to author regulatory-quality documentsAbility to deliver accurate results on time within GMP quality systems (Veeva, LIMS, Spotfire)Excellent written and verbal communication skills across all levels of the organization, with the ability to build cross-functional relationshipsProven ability to work independently and manage time-sensitive activities across teamsContinuous improvement mindset with experience applying lean practicesProficiency in MS Office (Word, Excel, PowerPoint, Teams) Good-to-Have Skills Experience managing GMP stability programs for pharmaceutical products in compliance with FDA and ICH regulationsExperience with authoring, assembling, and reviewing annual product reviewsExpertise in GMP applications (Veeva, Spotfire, SHINY) and proficiency in MS Office (Word, Excel, PowerPoint, Teams)Experience collaborating across time zones in a global, matrixed team environment Soft Skills Strong analytical and problem-solving mindsetStrong initiative and self-motivation to drive results under pressureAbility to work independently and balance multiple priorities while meeting challenging deadlinesTeam-oriented approach with a focus on achieving shared goalsStrong presentation and public speaking skills for inspections and cross-team updates *CO/NYC candidates might not be considered