Senior Specialist, Qa Operations, Batch Record Review

The Role
Moderna is seeking a Senior Quality Assurance Specialist reporting to the Manager, Quality Assurance. This position will be based in our cGMP Manufacturing site in Burlington and Norwood, MA and will directly support the growing CMC development programs at the Burlington, MA site. The main responsibility for this position is to provide quality oversight for batch record review and participate in disposition of GMP materials. The individual in this role will be responsible for participating GMP batch disposition for clinical products manufactured at Moderna. This individual will develop and execute based upon implemented quality systems / standards. The individual will work with internal functions to ensure robust processes and systems are implemented in support of Moderna’s CMC development programs. Strong decision-making skills and independent thinking will be paramount for candidate success. The individual will work closely with Manufacturing, and Quality Control.
Here’s What You’ll Do
Perform all activities required for batch disposition of GMP Materials
Identify risks and communicate gaps for quality and GMP process/systems.
Write, review, and approve GMP documentation (SOPs, protocols, technical reports, specifications, etc.)
Oversee and review executed electronic and paper batch record documentation.
Develop/Revise batch records, SOPs and training materials
Review batch records, associated testing records, and other documentation to ensure that all steps have been executed correctly, verified where applicable, and that all limits and specifications have been met
Reviews manufacturing deviations
Review protocols, analytical results, and documents associated with investigations, OOS results, etc., and corrective/preventive action plans
Closely partner with peers to support disposition of Moderna’s Products
Make quality decisions that may impact operations, ensuring appropriate escalation.
Authors and reviews SOPs, policies to ensure compliance and adherence to regulations/cGMP operations.
Participate in quality focused teams across Moderna’s broad ecosystem of functions
Collaborate with Manufacturing and Quality Operations to ensure rapid disposition of clinical products
Demonstrate general knowledge of standard manufacturing compliance, quality disposition, quality system review.
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.
Monitor process operations to ensure compliance with specifications.
Practice safe work habits and adhere to Moderna’s safety procedures and guidelines.
Utilize knowledge to improve operational efficiency.
Work closely with others to recognize opportunities for improvement and drive change through the use of Quality systems.
Additional duties as may be assigned from time to time
Here’s What You’ll Need (Minimum Qualifications)
BS or equivalent and 3 years of experience, or a Master’s level degree and 1 years’ experience in the pharmaceutical/biotech industry
Demonstrated knowledge of GMPs.
Strong written and oral communication skills as well as organizational skills.
Ability to travel occasionally (up to 25%) to support project activities.
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:
Highly competitive and inclusive medical, dental and vision coverage options
Flexible Spending Accounts for medical expenses and dependent care expenses
Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
Family care benefits, including subsidized back-up care options and on-demand tutoring
Free premium access to fitness, nutrition, and mindfulness classes
Exclusive preferred pricing on Peloton fitness equipment
Adoption and family-planning benefits
Dedicated care coordination support for our LGBTQ+ community
Generous paid time off, including:

• D iscretionary year-end shutdown
• Paid sabbatical after 5 years; every 3 years thereafter
• Volunteer time to participate within your community
• Vacation, sick time and holidays

Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
401k match and Financial Planning tools
Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
Complimentary concierge service including home services research, travel booking, and entertainment requests
Free parking or subsidized commuter passes
Location-specific perks and extras!
About Moderna
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.
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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