Specialist, Dna On-The-Floor Jobs

The Role

Moderna is seeking a Quality Assurance On the Floor (OTF) Sr Specialist reporting to the Manager, Quality Assurance. This position will be based in our cGMP Manufacturing site in Burlington, MA and will directly support the growing CMC development programs at the Burlington, MA site. The main responsibility for this position is to provide real time on the floor quality oversight of manufacturing and Facilities, with a focus on deviations, change controls, CAPAs, and method qualifications/validations. Strong decision-making skills and independent thinking will be paramount for candidate success. The individual will work closely with Manufacturing, Quality Control, and Facility teams. The shift is 1st shift from 7:00AM to 7:00PM Sunday through Wednesday or Wednesday through Saturday.

Here’s What You’ll Do

• Additional duties as may be assigned from time to time
• Partners with manufacturing and support teams to initiate and triage new deviation events, reviews minor and major manufacturing deviations.
• Make quality decisions that may impact operations, ensuring appropriate escalation to management when needed.
• Participate in quality oversight of manufacturing through real-time observations of activities.
• Enforce adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation. Establish and follow written procedures for the clear and accurate documentation of equipment operation and process instructions, and of process data.
• Identify risks and communicate gaps for quality and GMP process/systems.
• Supports, reviews and approves Deviations and change controls
• Support quality decisions that may impact operations, ensuring appropriate escalation.
• Monitor process operations to ensure compliance with specifications.
• Collaborate and lead effectively in a dynamic, cross-functional matrix environment
• Demonstrate general knowledge of standard manufacturing compliance, quality disposition, quality system review.
• Work closely with others to recognize opportunities for improvement and drive change through the use of Quality systems.
• Oversees execution of remediation/CAPA activities required to continue production or move a process to the next milestone.
• Support internal audits.
• Perform routine walkthroughs of the manufacturing suites partnering with manufacturing on suite maintenance, Quality best practice implementation and troubleshooting when problems arise.
• Utilize knowledge to improve operational efficiency.
• Practice safe work habits and adhere to Moderna’s safety procedures and guidelines.
• Authors and reviews SOPs, policies to ensure compliance and adherence to regulations/cGMP operations.
• Provide quality on-the-floor support of manufacturing, reviewing documentation, and providing real-time support of manufacturing issues change overs etc.
• Ability to manage multiple projects in a fast-paced environment.
• Identify risks and communicate gaps for quality and GMP process/systems.
• Collaborate with Manufacturing and Quality Operations to ensure rapid disposition of clinical products
• Reviews and approves facility alarms, facility work order requests, and return-to-service documentation.
• Participate in quality focused teams across Moderna’s broad ecosystem of functions

Here’s What You’ll Need (Minimum Qualifications)

• Strong written and oral communication skills as well as organizational skills.
• Demonstrated knowledge of GMPs.
• Ability to travel occasionally (up to 25%) to support project activities.
• BS or equivalent and 3 - 5 years of experience, or a Master’s level degree and 2 years’ experience in the pharmaceutical/biotech industry

Here’s What You’ll Bring to the Table (Preferred Qualifications)

• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Discretionary year-end shutdown
• Location-specific perks and extras!
• Adoption and family-planning benefits
• Free parking or subsidized commuter passes
• 401k match and Financial Planning tools
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Vacation, sick time and holidays
• Highly competitive and inclusive medical, dental and vision coverage options
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Generous paid time off, including:
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Paid sabbatical after 5 years; every 3 years thereafter
• Exclusive preferred pricing on Peloton fitness equipment
• Dedicated care coordination support for our LGBTQ+ community
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Free premium access to fitness, nutrition, and mindfulness classes
• Volunteer time to participate within your community

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 [email protected]. (EEO/AAP Employer)

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