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Specialist, On-The-Floor, Quality Assurance
Salary not available. View on company website.
Moderna Therapeutics, Oxford
- Onsite working
- Full time
- Permanent
Posted today, 30 Mar
Job ref: 694fb43ad86c4a269d04f001acbba5c2
Full Job Description
Joining 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's mission is to establish a leading-edge research, development, and manufacturing facility at Harwell, as part of a long-term commitment to onshore mRNA vaccine production for respiratory diseases. This initiative will create a multitude of highly skilled jobs and foster collaboration with academic, NHS, and government partners across the UK. We're looking for global experts eager to join us in this endeavor, contributing to a future where access to life-saving vaccines is a reality for all. As a Quality Specialist - Manufacturing Oversight, you will provide real-time, on-the-floor quality oversight for internal manufacturing at Moderna's Harwell site. You will be an integral part of a cohesive team supporting cGMP mRNA drug substance production and ensuring stringent adherence to Moderna's Quality System. Working cross-functionally with Operations, Manufacturing Science and Technology, and other key functions, you will bring strong decision-making skills and independent thinking to enable technical and regulatory compliance. In this role, you will be expected to make key quality decisions and escalate issues as needed during operations. Here's What You'll Do Your key responsibilities will be:
- Provide on-the-floor Quality oversight during manufacturing, ensuring real-time monitoring and compliance.
- Make quality decisions and escalate operational issues that impact production.
- Monitor process operations to ensure compliance with specifications, cGMPs, SOPs, and quality documentation.
- Perform routine walkthroughs of manufacturing suites to ensure appropriate suite maintenance and GMP best practices.
- Support deviation triage and investigation processes, reviewing minor manufacturing deviations.
- Author and review quality documentation, including SOPs and Work Instructions (WIs), ensuring alignment with compliance regulations.
- Review executed electronic and paper batch records to confirm adherence to regulatory requirements.
- Drive operational efficiency through quality-driven process improvements.
- Ensure adherence to Moderna's safety procedures and guidelines.
- Operate within a shift-based structure, supporting manufacturing schedules. Your responsibilities will also include:
- Working closely with Manufacturing, Operations, and Technical teams to drive compliance and operational excellence.
- Identifying risks and communicating gaps related to quality, GMP processes, and compliance systems.
- Supporting continuous improvement initiatives to strengthen quality and manufacturing processes.
- Collaborating with cross-functional teams to uphold the highest levels of product integrity and manufacturing efficiency.
- Remaining agile and adaptable in a fast-paced, high-impact manufacturing environment. The key Moderna Mindsets you'll need to succeed in the role:
- We act with urgency - Real-time quality oversight requires immediate decision-making and proactive risk mitigation to prevent compliance or manufacturing disruptions. Your ability to act decisively will directly impact production success.
- We behave like owners - This role requires independent thinking and strong accountability to uphold Moderna's quality standards. You will take ownership of decisions, manufacturing quality, and continuous improvement.
Bachelor's Degree in a science field (e.g., Biology, Microbiology, Chemistry, Pharmacy, Engineering) or equivalent combination of education and experience - 3 - 5 years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices, A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work. We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with: - Quality healthcare and insurance benefits
- Lifestyle Spending Accounts to create your own pathway to well-being
- Free premium access to fitness, nutrition, and mindfulness classes
- Family planning and adoption benefits
- Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown
- Educational resources
- Savings and investments
- 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 employment opportunity 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 also consider qualified applicants regardless of criminal histories, consistent with legal requirements. Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best. Moderna is committed to offering reasonable accommodations 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
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