Quality Control Associate, Bioassay
3 days ago
Colmenar Viejo
ppIf you’re interested in this role, please apply in English and include an English version of your Resume/CV. /p h3The Role /h3 pJoining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients. Moderna is strengthening its international centre for analytical excellence in Madrid, the largest of its kind outside the United States. The site supports our global manufacturing network and advancing mRNA portfolio. We welcome talent ready to drive innovative research and development. Join our Quality Control Bioassay team and play a critical role in ensuring the quality, safety, and consistency of Moderna’s innovative mRNA medicines. In this laboratory‑based individual contributor role, you will perform cGMP QC testing supporting In Vitro Relative Protein Expression (IVRPE), release and stability testing, while contributing to method qualification, continuous improvement, and operational excellence. Working in a highly regulated GMP environment, you will combine strong scientific expertise with rigorous quality standards to generate reliable analytical data that supports product release and long‑term stability. You will also have opportunities to work alongside digital and Generative AI‑enabled tools that continue to enhance laboratory operations, data analysis, and scientific decision‑making across Moderna. /p h3Here’s What You’ll Do /h3 ul liPerform cGMP Quality Control Bioassay testing with a focus on In Vitro Relative Protein Expression (IVRPE), supporting release and stability programs. /li liSupport Method Qualification and Acquisition activities as required. /li liPerform routine analytical bioassay testing supporting Cell Biology, including ELISA methodologies. /li liExecute analytical testing accurately and in accordance with approved procedures and regulatory requirements. /li liPerform general laboratory support activities including reagent preparation, sample management, equipment maintenance, laboratory housekeeping, and ensuring laboratory readiness. /li liPerform LIMS (LabVantage) sample result entry and execute Electronic Assay Forms within LIMS. /li liSupport stability programs through timely testing and documentation. /li liPerform data entry and contribute to data trending activities. /li liManage and maintain QC laboratory supplies and inventory. /li liAssist with troubleshooting analytical methods and laboratory equipment where required. /li liSupport investigations related to Out of Specification (OOS) results and other non‑conforming events. /li liParticipate in quality systems activities including investigations, deviations, change controls, and CAPAs. /li liWrite, revise, and maintain Standard Operating Procedures (SOPs), protocols, technical reports, and other controlled documentation. /li liComplete and maintain accurate cGMP documentation for all work performed. /li liExecute work precisely in accordance with Standard Operating Procedures (SOPs), work instructions, and other internal guiding documents. /li liFollow Good Documentation Practices and Data Integrity requirements to ensure records are accurate, complete, and inspection‑ready. /li liEnsure compliance with all applicable GxP regulations, internal policies, and regulatory expectations. /li liEstablish and maintain a safe laboratory working environment while promoting a culture of quality, compliance, and continuous improvement. /li /ul h3The key Moderna Mindsets you’ll need to succeed /h3 ul liWe obsess over learning. We don’t have to be the smartest we have to learn the fastest. /li liWe digitize everywhere possible using the power of code to maximize our impact on patients. /li /ul h3Basic Qualifications /h3 ul liTechnical qualification (FP, ciclo superior) or degree in Cell Biology, Molecular Biology, Biochemistry, or other relevant scientific discipline with at least 2 years’ experience /li liWorking experience: minimum 2 years’ experience in quality control laboratory of a pharmaceutical company is preferred. /li liHands‑on experience with cell‑based assays and biological systems, cell culture, transfection, ELISA or other immunoassays. /li liWorking knowledge of relevant and current FDA, EU, ICH guidelines and regulations preferred. /li liAbility to collaborate effectively in a dynamic, cross‑functional matrix environment. /li liAbility to efficiently prioritize and complete multiple projects and tasks in a fast‑paced environment. /li liWorking proficiency in English, minimum B2 level required. /li /ul h3Pay Benefits /h3 ul liCompetitive healthcare, plus voluntary benefit programs to support your unique needs /li liA holistic approach to well‑being with access to fitness, mindfulness, and mental health support /li liFamily building benefits, including fertility, adoption, and surrogacy support /li liGenerous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year‑end shutdown /li liSavings and investments to help you plan for the future /li liLocation‑specific perks and extras /li /ul pModerna is a smoke‑free, alcohol‑free, and drug‑free work environment. /p pModerna is committed to equal opportunity in employment and non‑discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. /p pModerna is committed to offering reasonable accommodation or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations and Adjustments team at /p /p #J-18808-Ljbffr