- Assist in migration of data into the Veeva Audit Management System
- Train in the conduct of clinical (GCP) audits (non-travel)
- Contribute to the maintenance of audit tracking tools
- Aid in the creation of documentation for Moderna conducted audits
- Learn about current regulatory requirements by contributing to the development of quarterly newsletter and regulatory intelligence activities
- Learn about Quality study team support
- Accept candid feedback and seek opportunities for self-improvement
- Engage in various departmental activities and attend relevant meetings as required
- Assist in preparation for Health Authority inspections
- Contribute to Quality Optimization efforts in training administration, procedural documents and metrics/reporting Competencies and Benefits of this role:
- Gain real life experience in a dynamic and growing R&D quality function that supports clinical trials, non-clinical laboratories and pharmacovigilance activities
- Work closely with seasoned R&D Quality professionals that will provide excellent mentorship opportunities through a variety of lenses and experiences
- Receive training and gain firsthand experience with R&D Quality across the various GXPs (GCP/GLP/GVP/CSV)
- Gain a keen understanding of the audit process and opportunities to shadow auditors during audits.
- Exposure to the various GXP functional groups that RDQ supports Heres What Youll Bring to the Table:
- Currently enrolled as a student working towards a bachelors degree in a science focused program (i.e., Biology, Chemistry, Pharmacy) or similar
- At least 3 years of study in one of the above scientific fields preferred
- Basic familiarity with pharmaceutical regulations (GCP, GVP, GLP, CSV) is a strong plus
- Must possess excellent organization skills and ability to manage multiple priorities
- Excellent verbal and written communication skills and the ability to interact professionally with a diverse group, executives, managers, and subject matter experts
- Willingness to learn, be mentored, and improve
- Ability to work independently and in collaborative team environments
- Ability to work in a fast-paced demanding environment
- Ability to prioritize based on shifting demands
- Ability to work independently, prioritize, multitask, know when to ask for help
- Willing and able to relocate to Cambridge, MA for the co-op
- Indefinite right to work in the United States without the need for sponsorship now or in the future. 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:
Vacation, sick time and holidays
Volunteer time to participate within your community
Discretionary year-end shutdown
Paid sabbatical after 5 years; every 3 years thereafter- 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 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 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 (EEO/AAP Employer)
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2024 Co-Op, R&D Quality - Cambridge, United States - Moderna, Inc.
Description
The Role:
Modernas R&D Quality (RDQ) group is seeking a highly motivated 3rd/ 4th year colleague student that has an interest in Quality Assurance in the R&D environment within the biotech/pharma industry. This position provides an opportunity for inquisitive students who are currently pursuing a Biology, Chemistry, or Pharmacy degree to get hands on experience working with a R&D Quality team in a fast-paced environment providing proactive compliance guidance and support across all RDQ GXPs (GCP/GLP/GVP/CSV). The R&D Quality Co-Op will also contribute to key development projects and help advance the overall maturity of our program.
If you are bold, relentless, collaborative, and obsess over learning, an internship at Moderna can help augment your education and accelerate your career.
Our co-op program will run from July 15th- December 13th. All applicants must be available to work full-time for the entire duration of the program.
The R&D Quality Co-Op role will focus on assisting RDQ staff with the maintenance of audit trackers, preparing audit-related documents and aid in the compilation of periodic regulatory updates. This position will also assist with supporting Health Authority inspections and the migration of audit data and records into the Veeva Audit Management System. The Co-Op program will also provide the opportunity for the Co-Op to observe experienced RDQ Auditors in conducting clinical study, vendor, and pharmacovigilance audits. The candidate must also possess the ability to effectively interact and collaborate in a dynamic, cross-functional matrix environment.
Heres What Youll Do:
