Specialist, Quality Control Chemistry & Stability

Detalles de la oferta

.The RoleJoining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives. Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience with the potential to make a significant impact on patients' lives worldwide.Moderna is solidifying its footprint within our international centre for analytical excellence in Madrid, a city known for its rich scientific heritage. This facility, the largest such center outside the United States, exemplifies our commitment to solidifying our manufacturing network and advancing our promising mRNA product portfolio. We're looking for talents who can contribute to our innovative research and development efforts.In this role, you will work as part of the Quality Control team based in Madrid, Spain, reporting to the Quality Control Manager. You will be responsible for performing cGMP QC testing for QC Chemistry, release, and stability programs. You will also support global GMP stability programs, including activities such as stability sample set down, pull, and sample shipment/receipt. In addition, you will maintain stability databases, perform data trending and statistical analysis, and contribute to the creation, revision, and review of SOPs, protocols, and reports according to GMP, FDA, EU, and ICH guidelines. This role will provide opportunities to engage in special projects, continuous improvement initiatives, and participate in audits as needed.Here's What You'll DoYour key responsibilities will be: Performing statistical analysis and trending of stability data following SOPs and ICH guidelines. Creating, reviewing, and revising stability protocols and reports, including specification documents. Managing stability studies in LIMS, performing data entry and review as necessary. Supporting stability chamber maintenance, troubleshooting, and temperature data interpretation. Your responsibilities will also include: Ensuring the organization and maintenance of stability chambers and walk-ins. Assisting in the shipment and receipt of samples for external testing or storage. Managing GMP stability schedules and sample pulls to meet deadlines. Participating in audits and contributing to regulatory submissions and reports. Engaging in the continuous improvement of stability programs and compiling relevant metrics. Supporting reference standard and cell bank stability programs and ensuring compliance with cGMP and safety standards


Salario Nominal: A convenir

Fuente: Jobtome_Ppc

Requisitos

V484 - Control De Accesos Alcobendas (Val. Discapacidad)

Somos Grupo SIFU, Centro Especial de Empleo líder en la prestación de Facility Services socialmente responsables. Con 25 años de experiencia y más de 4.500 p...


Sifu Madrid - Madrid

Publicado 16 days ago

(Zx-237) Nav/Bc - Consultant

ResumenEn Prodware nos encontramos en un periodo de fuerte crecimiento y estamos buscando gente como tú para que formes parte de nuestro equipo de especialis...


Prodware - Madrid

Publicado 17 days ago

N-723 - Profesional De Limpieza Para Limpieza De Casa (Periódica)

Frecuencia de la limpieza: Más de una vez por semana.Tipo de propiedad: Casa (Chalet o Adosado).No de habitaciones: 3 habitaciones.No de cuartos de baño: 3 b...


Zaask - Madrid

Publicado 17 days ago

Quality Tester French Speaker

Quality Tester French native speaker We are looking for a self-starting, proactive problem solver to join our Quality Assurance team!As part of this team, yo...


Cognizant - Madrid

Publicado 17 days ago

Built at: 2024-11-13T09:30:19.003Z