Title:                        Specialist, On-the-Floor, Quality Assurance (Shift)

Location:             Harwell, UK

Reports to:         QA Operations Head (Helen O' Callaghan)

The Role:

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 strategic partnership with the UK Government is exemplified by our innovative presence at Harwell. Our mission is to establish a leading-edge research, development, and manufacturing facility 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 and NHS 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​​.

We are seeking a Quality Assurance Specialist for real-time quality oversight of internal manufacturing at Moderna Inc., located at our Harwell, UK site. This role involves being part of a cohesive team responsible for supporting cGMP mRNA drug substance production internally. The successful candidate will work cross-functionally with Operations, Manufacturing Science and Technology, and other departments, providing real-time quality oversight and expertise to ensure technical success with strict adherence to the Quality System. This position requires strong decision-making skills, independent thinking, and the ability to make or escalate decisions regarding operations as needed.

Here’s What You’ll Do:

Your key responsibilities will be:

• Providing on-the-floor Quality support to Manufacturing, including real-time observation of activities and monitoring process operations to ensure compliance with specifications.

• Making quality decisions and/or escalating issues to management that may impact operations, identifying risks, and communicating gaps for quality and GMP process/systems.

• Performing routine walkthroughs of the manufacturing suites to ensure appropriate suite maintenance, implementation of GMP best practices, and troubleshooting when problems arise.

• Enforcing adherence to cGMPs, SOPs, and manufacturing documentation.

• Partnering with manufacturing and support teams to initiate and triage new deviation events, reviewing minor manufacturing deviations.

• Authoring and reviewing documentation, including SOPs and WIs, to ensure compliance and adherence to regulations/cGMP operations, and reviewing executed electronic and paper batch record documentation.

• Practicing safe work habits and adhering to Moderna’s safety procedures and guidelines.

• Utilizing knowledge to improve operational efficiency.

• Operating on a shift structure.

Your responsibilities will also include:

• Engaging in continuous learning and development related to quality assurance, cGMP practices, and operational efficiency.

The key Moderna Mindsets you’ll need to succeed in the role:

• We push past possible: Demonstrating a relentless pursuit of innovation and operational excellence in quality assurance.

• We pivot fearlessly: Adapting quickly to operational challenges and changes in manufacturing processes with a solutions-oriented approach.

Here’s What You’ll Bring to the Table:

• 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

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.

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 proud to be an equal opportunity workplace and is an affirmative action employer.

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. Moderna is an E-Verify Employer in the United States. 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 to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com.  (EEO/AAP Employer) 

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