Senior Specialist, Quality Control, Chemistry (Madrid)

Senior Specialist, Quality Control, Chemistry (Madrid)

04 ago
|
Moderna
|
Madrid

04 ago

Moderna

Madrid

ph3Overview /h3 pJoining Moderna means advancing mRNA science to transform medicine. Work with global teams on a broad pipeline and build a career that makes a real difference for patients. Moderna’s international analytical center in Madrid supports our integral manufacturing network and enhances the mRNA portfolio. The role is an individual contributor position focused on quality, integrity, and compliance of QC Chemistry activities supporting release and stability testing across the mRNA portfolio. /p h3Responsibilities /h3 ul liPerform cGMP Quality Control data review for QC Chemistry, including release and stability testing, and support method qualification and acquisition activities. /li liSupport method transfers and method development to ensure robust analytical capabilities. /li liReview executed assay packages in paper and electronic formats, including chromatography data and other analytical outputs. /li liEnsure laboratory testing is performed accurately and in full compliance with cGMP, GDP, Data Integrity, and Good Documentation Practices requirements. /li liMaintain GMP compliance across QC laboratory operations. /li liSupport stability program activities, including review of stability data packages and associated documentation. /li liPerform data entry activities and support laboratory data trending. /li liLead troubleshooting activities for analytical methods and laboratory equipment. /li liParticipate in cross‑functional planning activities to align QC resources and laboratory constraints with business objectives. /li liSupport and mentor junior team members through technical guidance, troubleshooting, and training. /li liAuthor, review, and approve SOPs, analytical test methods, QC release documentation, instrument qualification documentation, computer system validation documentation, training materials, and method lifecycle documentation. /li liDevelop and manage scheduling and status monitoring tools to track testing capacity, turnaround times, and communicate laboratory progress across the organization.



/li liProvide compliance guidance and support to the QC Chemistry team, including preparation for, participation in, and response to internal and external compliance audits. /li liPerform and/or support Certificate of Analysis generation and preparation of stability data, including review and maintenance of cGMP documentation supporting all laboratory activities. /li liLead Quality System records, including investigations, Out of Specification events, deviations, change controls, and Corrective and Preventive Actions (CAPAs). /li liExecute work precisely in accordance with internal procedures, Standard Operating Procedures (SOPs), work instructions, and applicable GxP regulations. /li liEnsure documentation, records, and laboratory data are audit‑ready and maintained to support regulatory inspections. /li liSupport special projects that contribute to continuous improvement, operational excellence, and laboratory collaboration with Quality, Manufacturing, and Technical Development. /li liLeverage emerging digital technologies, including Generative AI tools where appropriate, to improve efficiency and knowledge sharing. /li /ul h3Mindsets /h3 ul liObsess over learning: we emphasize learning fast over being the smartest. /li liAct as owners: solutions build beyond a job description. /li /ul h3Basic Qualifications /h3 ul liBA/BS in Chemistry (preferred) or other relevant scientific discipline. /li li+5 years experience in quality control laboratory of a pharmaceutical company. /li liExperience with analytical chemistry review, including chromatographic techniques (HPLC, UPLC), spectroscopic and spectrometric techniques, and physical property techniques such as Particle Analysis by Dynamic Light Scattering.



/li liExperience in a GMP environment. /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 prioritize and complete multiple projects and tasks in a fast‑paced environment. /li liWorking proficiency in English, minimum C1 level required. /li /ul h3Pay Benefits /h3 pModerna offers a holistic approach to well‑being with access to fitness, mindfulness, and mental health support; family‑building benefits, including fertility, adoption, and surrogacy support; generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year‑end shutdown; savings and investments to help plan for the future; and location‑specific perks and extras. Benefits may vary based on employment type and country of work. /p h3Equal Opportunity Statement /h3 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 h3Accommodation Statement /h3 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 should contact the Accommodations and Adjustments team at /p h3Location /h3 pSenior Specialist, Quality Control, Chemistry – Madrid, Kingdom Of Spain, ES /p /p #J-18808-Ljbffr

📌 Senior Specialist, Quality Control, Chemistry (Madrid)
🏢 Moderna
📍 Madrid

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