Moderna · 1 month ago
Specialist, Quality Control, Data Management
Quality
Full-time
Onsite
Mid Level
3+ years expModerna is a pioneering company revolutionizing medicine through mRNA technology, with a focus on global health initiatives. The Quality Control Compliance Specialist will ensure the integrity and compliance of QC documentation and data reporting, collaborating across various teams to uphold high standards in data integrity and compliance.
BiotechnologyGeneticsHealth CareMedicalPharmaceuticalTherapeutics
Responsibilities
Author and/or approve QC Certificates of Analysis and stability data packages, ensuring full compliance with protocols, specifications, and standards
Perform thorough compliance reviews of QC data reports, verifying all associated laboratory documentation has been properly reviewed and approved
Ensure timely closure of all laboratory events, OOX investigations, and deviations prior to finalizing COAs or data reports
Collaborate with the QC Lab Systems team to ensure alignment and digital compliance within QC reporting systems
Conduct and/or participate in investigations for QC deviations, ensuring progression adheres to procedural timelines
Implement or support effective CAPAs for lab events and deviations where assigned
Contribute to stakeholder assessments for change controls involving QC
Identify areas for continuous improvement and propose or help implement compliant solutions across QC processes
Support various inspection readiness activities to uphold audit preparedness
Accept and deliver on special assignments as needed, in accordance with procedural timelines and GxP compliance expectations
Qualification
Required
BS in a relevant scientific discipline (Science, Engineering and Business)
Working experience: +3 years ‘experience in quality control laboratory of a pharmaceutical company
Working experience in a GMP environment
Ability to collaborate effectively in a dynamic, cross-functional matrix environment
Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment
This position is site-based, requiring you to be at Moderna's site full-time. This position is not eligible for remote work
Preferred
Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations preferred
Benefits
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, global recharge days, and a discretionary year-end shutdown
Savings and investments
Location-specific perks and extras!
Company
Moderna
Moderna Therapeutics is a biotechnology company that specializes in vaccines and drug development.
1001-5000 employees
H1B Sponsorship
Moderna has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (42)
2024 (49)
2023 (55)
2022 (23)
2021 (58)
2020 (19)
Funding
Current Stage
Public CompanyTotal Funding
$4.56BKey Investors
Coalition for Epidemic Preparedness InnovationsAres ManagementU.S. Department of Health & Human Services
2025-12-18Grant· $54.3M
2025-11-20Post Ipo Debt· $600M
2024-07-02Grant· $176M
Leadership Team
Stephane Bancel
Founding CEO
Kenneth Chien
Co-Founder
Recent News
2026-01-12
Company data provided by crunchbase