2025 Co-Op, R&D Quality and Compliance

Moderna Therapeutics • Norwood, MA

293d

About The Position

Moderna's R D Quality and Compliance (RDQ&C) group is seeking a highly motivated college student that has an interest in Digital Quality Assurance and Laboratory Quality in the RDQ&C environment within the biotech/pharma industry. This position provides an opportunity for inquisitive students who are currently pursuing a degree in Life Sciences, Computer Science, Engineering, Data Science or related field to get hands on experience working with the RDQ&C Digital Quality team and RDQ&C Laboratory Quality team in a fast-paced environment providing proactive digital compliance guidance and support across all RDQ&C GXPs (GCP/GLP/GVP/CSV). The RDQ&C Co-Op role will support the integrity, security, and performance of digital systems in Moderna's R D operations, ensuring that laboratory, clinical, and pharmacovigilance systems comply with regulatory requirements for electronic records and signatures. Additional contributions include reviewing assay method validation documents and results for clinical sample analysis for study specific regulated processes, and opportunity to support audits for laboratory deliverables. The ideal candidate will have a good understanding of health authority regulatory requirements, digital system validation, lifecycle controls and the drug development process, as well as Quality Assurance (QA), clinical development and clinical sample analysis, and electronic record/electronic signature regulations and guidelines. If you are bold, relentless, collaborative, and obsess over learning, a co-op program at Moderna can help augment your education and accelerate your career. Our Fall co-op program will run from July 14 - December 12, 2025. All applicants must be available to work full-time and on site (Norwood, MA) for the entire duration of the program.

Requirements

• Currently pursuing a degree in Life Sciences, Computer Science, Engineering, Data Science, or a related field.
• Bioanalytical technology knowledge, including, but not limited to LIMS, PCR, plate readers, and mass spectroscopy proficiency is highly desired.
• Basic familiarity with pharmaceutical regulations (GCP, GVP, GLP, CSV) is a strong plus.
• Basic familiarity with Electronic Record and Electronic Signature requirements, including 21 CFR Part 11 regulation and ISPE GAMP 5 guidelines.
• Technical knowledge in Machine Learning and Artificial Intelligence preferred.
• Understanding of computer system validation and system lifecycle controls.
• Prior experience or coursework in Quality Assurance is a plus.
• Strong analytical and critical thinking skills, with excellent communication and teamwork abilities.
• Strong attention to detail with a dedicated commitment to upholding quality standards.
• Eagerness to learn, be mentored, and continuously improve.
• Ability to work both independently and collaboratively in a fast-paced, demanding environment.
• Skilled in multitasking and prioritizing tasks in response to shifting demands.
• Willing and able to relocate to Norwood, MA for the co-op.
• Indefinite right to work in the United States without the need for sponsorship now or in the future.

Responsibilities

• Support QA audits of digital systems and laboratory deliverables, providing QA oversight for digital system implementations.
• Assist in validation and lifecycle management compliance to meet regulatory standards.
• Collaborate with team members to develop and maintain R D digital systems compliant with regulations and guidelines.
• Learn QA oversight best practices for digital system implementation phases.
• Review validation documentation to ensure quality and compliance.
• Contribute to risk impact assessments and evaluate potential digital system risks.
• Identify and resolve digital system compliance issues under guidance.
• Overview of audit study materials and reports for nonclinical, biomarker and bioanalytical studies.
• Assist audit team with audit deliverables, CAPAs and responses.

Benefits

• Free premium access to meditation and mindfulness classes.
• Subsidized commuter benefits.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Intern
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree