Specialist, Quality Assurance (QA)
Specialist, Quality Assurance (QA)
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Salary Not Disclosed
1 Vacancy
Job Description
The Role:
ModernaTX Inc. seeks a Specialist Quality Assurance (QA) for its Norwood Massachusetts location.
Heres What Youll Do:
Participate in quality focused teams across Modernas broad ecosystem of functions.
Oversee and review executed electronic and paper batch record documentation and work cross-functionally to drive corrective actions as needed.
Execute and review disposition packages to perform Good Manufacturing Practices (GMP) release of drug product for clinical use.
Enforce adherence to current Good Manufacturing Practices (cGMP) Standard Operating Procedures (SOPs) and manufacturing documentation.
Utilize knowledge to improve operational efficiency and participate in continuous improvement projects.
Write update and revise procedures and work instructions.
Monitor process operations to ensure compliance with regulatory requirements policies and procedures.
Practice safe work habits and adhere to Modernas safety procedures and guidelines.
Follow all relevant Good Practices (GxP) regulations guidelines and company policies to ensure compliance with regulatory and internal requirements.
Heres What Youll Bring to the Table:
Minimum requirements:
Requires a Masters degree in Project Management Regulatory Affairs or related field and 1 year of experience as a QA Associate Quality Control (QC)/QA Specialist or related position supporting quality assurance operations for pharmaceutical manufacturing.
1 year of experience must include:
Cross-functional project management;
Risk management and quality management for pharmaceutical products;
Batch record reviews & product disposition workflows for pharmaceutical manufacturing;
Ensuring cGMP & Good Distribution Practices (GDP) compliance; and
Veeva LIMS & MODA quality control systems.
May telecommute 2 days per month.
Apply at (Job ID: R17903) or email resume and cover letter to with subject line: R17903.
#DNI
At Moderna we believe that when you feel your best you can do your best work. Thats why our US benefits and global well-being resources are designed to support youat work at home and everywhere in between.
- Best-in-class healthcare coverage plus a suite of voluntary benefit programs to support your unique needs
- A holistic approach to well-being with access to fitness mindfulness and mental health support
- Lifestyle Spending Accounts to personalize your well-being journey
- Family planning and adoption benefits
- Generous paid time off including vacation volunteer days sabbatical global recharge days and a discretionary year-end shutdown
- Savings and investment opportunities
- Location-specific perks and extras
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 to learn more about our current opportunities.
Our Working Model
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.
Moderna is a smoke-free alcohol-free and drug-free work environment.
Equal Opportunities
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons 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 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 an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories consistent with legal requirements.
Accommodations
Were focused on attracting retaining developing and advancing our employees. By cultivating a workplace that values diverse experiences backgrounds and ideas we create an environment where every employee can 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 .
Export Control Notice
This position may involve access to technology or data that is subject to U.S. export control laws including the Export Administration Regulations (EAR). As such employment is contingent upon the applicants ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements only individuals who qualify as U.S. persons (citizens permanent residents asylees or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.
#LI-NB1-
Required Experience:
Unclear Seniority
Employment Type
Full-Time
