/Specialist, Quality Control, Sample Management

Specialist, Quality Control, Sample Management

Polandplvia direct
// Job Type
Full Time
// Salary
Not disclosed
// Posted
2 months ago
// Seniority
manager
// Work Mode
onsite
// Experience
3 years

About the Role

If you’re interested in this role, please apply in English and include an English version of your Resume/CV. The Role: Joining 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. As a Quality Control Sample Management Specialist reporting to the Manager of Quality Control Operations, you will own and execute critical cGMP sample management activities that underpin the integrity of our laboratory operations. You will serve as a central coordination point between internal Quality Control, Analytical Science & Technology teams, external laboratories, and contract manufacturing organizations (CMOs). This is a hands-on laboratory role where operational precision, digital fluency, and compliance excellence converge to enable safe, timely, and inspection-ready sample lifecycle management across our mRNA platform. Here's What You'll Do: Execute sample management processes exactly as defined in internal guiding documents, including Standard Operating Procedures (SOPs) and work instructions, ensuring strict adherence to cGMP requirements. Execute daily schedules to ensure safe and timely completion of sample processing activities and associated quality records. Manage, maintain, and troubleshoot Controlled Temperature Units (CTUs), ensuring environmental controls meet regulatory and internal standards. Support troubleshooting activities and provide guidance to resolve compliance issues within the sample management process. Author and revise SOPs, protocols, and quality system records, including deviations and CAPAs, ensuring robust documentation and sustainable corrective actions. Participate in weekly sample management scheduling and alignment meetings with internal stakeholders and external partners, ensuring operational clarity and coordination. Partner closely with the Digital team to expand and optimize the use of the Laboratory Information Management System (LIMS), driving digitization of workflows and strengthening data integrity. Collaborate with Quality Control and Analytical Science & Technology teams to continuously improve laboratory sample operations, enhancing quality, compliance, and efficiency. Train colleagues and oversee training assignments, ensuring compliance requirements remain current and aligned with regulatory expectations. Establish and maintain a safe laboratory working environment aligned with company safety standards and regulatory requirements. Foster a positive and inclusive culture that promotes collaboration, innovation, and continuous improvement across cross-functional interfaces. Follow all relevant GxP regulations, guidelines, and company policies to ensure full compliance with regulatory and internal requirements. Apply Good Documentation Practices (GDP) and Data Integrity principles to ensure data, documentation, and records are accurate, complete, and inspection-ready to support audits and regulatory inspections. Complete required training within assigned learning plans according to defined timelines and requalification cadence. In this role, you will also have the opportunity to contribute to ongoing digital transformation initiatives, leveraging advanced LIMS capabilities and engaging with emerging digital and Generative AI-enabled tools to enhance workflow automation, data review efficiency, deviation trend analysis, and knowledge management within QC operations. The key Moderna Mindsets you’ll need to succeed in the role: “We digitize everywhere possible using the power of code to maximize our impact on patients.” “We behave like owners. The solutions we’re building go beyond any job description.” Here’s What You’ll Need (Basic Qualifications): Education: Minimum: BA/BSc in a relevant scientific discipline Experience: Minimum: 3 years in Quality Control experience in a cGMP organization. Demonstrated aptitude or ability to learn: Able gain a strong understanding of GxP regulations. Working experience in a GMP environment. Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations preferred. Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work. That’s why our global benefits and well-being resources are designed to support you—at work, at home, and everywhere in between. Best-in-class healthcare, plus voluntary benefit programs to support your unique needs 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 you plan for the future Location-specific perks and extras The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work. About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! Moderna 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. We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Moderna 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 leavesandaccommodations@modernatx.com. - Our Mission and Vision At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission. Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients. Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today. Third Party Staffing Agencies Moderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes. Reasonable Accommodation Notice Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing humanresources@modernatx.com if you need assistance completing any forms or to otherwise participate in the application process. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment. Return Home

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