2025 Intern, NextGen Global Quality eCompliance
BioSpace, Inc. - norwood, MA
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Job Details The Role: This is a summer internship opportunity in Norwood, MA from June 2, 2025 August 15, 2025 . Applicants must be available for the entire duration of the internship. Start date will be June 2, 2025 . We are seeking a highly motivated and detail-oriented eCompliance Intern to join our team in a regulated pharmaceutical environment. The intern will support the Global Quality e-Compliance team in ensuring that all software products and systems comply with industry regulations, including GxP (Good Practice) guidelines, FDA 21 CFR Part 11, and other applicable standards. This is an excellent opportunity for someone looking to gain experience in quality assurance within a highly regulated industry, particularly in pharmaceutical software systems. Here's What Youll Do: Continuous Improvement Projects: Provide feedback and suggestions for process improvements in eCompliance practices/procedures, including developing a SmartSheet demand and resource planning for eCompliance department. Develop Teams site and taxonomy for eComplaince team including using team planner. Develop slide decks for GxP Computer System Validation Training. Validation Documentation: Assist in the creation and maintenance of software validation and verification documentation, including test plans, test scripts, and validation reports. Risk Assessments: Participate in software risk assessments to identify critical components and areas that require focused testing. Learning Opportunities: Gain hands-on experience in a regulated pharmaceutical software environment. Learn about regulatory compliance, software validation, and industry best practices. Exposure to a cross-functional team working on mission-critical software systems in a global pharmaceutical company. Heres What Youll Need: Currently pursuing a degree in Computer Science, Information Technology, Engineering, Life Sciences or a related field. Prior experience or coursework in software testing, quality assurance, or validation preferred. Understanding of regulatory requirements and experience in a GxP or FDA-regulated environment. Basic understanding of software quality assurance methodologies and testing practices. Demonstrated aptitude or ability to learn in order to gain a strong understanding of GxP regulations (GMP, 21 CFR Part 11, GAMP 5, Annex 11) Moderna is pleased to provide you with an innovative suite of benefits, including: Free premium access to meditation and mindfulness classes Free parking or subsidized commuter passes Generous paid time off, including: Vacation, sick time and holidays Volunteer time to participate within your community Discretionary year-end shutdown 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 /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 the Accommodations team at . (EEO/AAP Employer) -
Created: 2024-10-15