Specialist, Quality Assurance

4 weeks ago

Norwood, United States Moderna, Inc. Full time

The Role:

The Quality Assurance Specialist is part of a cohesive team responsible for supporting cGMP oversight of internal manufacturing at Moderna Inc.

Heres What Youll Do:

Provides on-the-floor Quality support to Manufacturing. Makes quality decisions and/or escalates issues to management that may impact operations.

Performs QA review of master batch records and electronic batch records

Perform routine walkthroughs of the manufacturing suites partnering with manufacturing on suite maintenance, Quality best practice implementation and troubleshooting when problems arise.

Participate in quality oversite of manufacturing through real-time observations of activities.

Monitor process operations to ensure compliance with specifications.

Demonstrate general knowledge of standard manufacturing compliance, quality disposition, quality system review.

Identifying risks and communicating gaps for quality and GMP process/systems

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.

Partners with manufacturing and support teams to initiate and triage new deviation events, reviews minor manufacturing deviations.

Support quality functional groups on as needed basis.

Authors and reviews SOPs, policies to ensure compliance and adherence to regulations/cGMP operations.

Practice safe work habits and adhere to Modernas safety procedures and guidelines.

Utilize knowledge to improve operational efficiency.

Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.

Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.

Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.

Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.

Heres What Youll Bring to the Table

Education: Minimum Bachelors degree in a scientific/engineering discipline or equivalent experience.

Experience: 5 years of experience in a GMP manufacturing environment or 3 years of experience with a Bachelor's degree.

Demonstrated aptitude or ability to learn to gain a strong understanding of GxP regulations (specify GMP, GLP, GCP, GVP or other applicable standards).

This position is site-based, requiring you to be at Modernas site full-time. This position is not eligible for remote work.

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

Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classesExclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:
Vacation, sick time and holidays
Volunteer time to participate within your community
Discretionary year-end shutdown
Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure 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 peopleare 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 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. Were 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 contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)

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